Sterling Diagnostics, Inc.
Sterling Heights, MI, US
Sterling Diagnostics, Inc. appears in FDA device records in Sterling Heights, MI. FDA records list 41 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 41 510(k) clearances for Sterling Diagnostics, Inc. between 1985 and 1993. The busiest year on record is 1986, with 36. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 36 |
| 1991 | 3 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K921412 | MICROPROTEIN REAGENT SET | CEK | Substantially Equivalent | |
| K914609 | TRIGLYCERIDES REAGENT SET | CDT | Substantially Equivalent | |
| K914039 | SODIUM REAGENT SET | CEI | Substantially Equivalent | |
| K914040 | PHOSPHOLIPID REAGENT SET | JNT | Substantially Equivalent | |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | CFJ | Substantially Equivalent | |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | CDF | Substantially Equivalent | |
| K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET | CJE | Substantially Equivalent | |
| K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) | CDQ | Substantially Equivalent | |
| K862209 | ALT (SGPT) REAGENT SET (UV RATE) | CKA | Substantially Equivalent | |
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | JKF | Substantially Equivalent | |
| K861713 | SERUM POTASSIUM REAGENT SET | CEJ | Substantially Equivalent | |
| K861615 | SALICYLATE REAGENT SET | DKJ | Substantially Equivalent | |
| K861311 | GLUCOSE (HEXOKINASE) REAGENT SET | CFR | Substantially Equivalent | |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | DLI | Substantially Equivalent | |
| K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET | CIT | Substantially Equivalent | |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | CKD | Substantially Equivalent | |
| K860477 | URIC ACID REAGNET SET (TRINDER) | KNK | Substantially Equivalent | |
| K860216 | SGOT (AST) REAGENT SET | CIQ | Substantially Equivalent | |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | JPZ | Substantially Equivalent | |
| K860214 | TOTAL BILIRUBIN REAGENT SET | CIG | Substantially Equivalent | |
| K860628 | INORGANIC PHOSPHORUS REAGENT SET | CEO | Substantially Equivalent | |
| K860554 | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) | CFG | Substantially Equivalent | |
| K860478 | SERUM IRON & IRON BINDING REAGENT SET | JIY | Substantially Equivalent | |
| K860476 | ACID PHOSPHATASE REAGENT SET | CKE | Substantially Equivalent | |
| K860475 | HEMOGLOBIN REAGENT SET | KHG | Substantially Equivalent | |
| K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) | CJA | Substantially Equivalent | |
| K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET | CFH | Substantially Equivalent | |
| K860420 | SICKLE CELL REAGENT SET | GHM | Substantially Equivalent | |
| K860340 | SERUM ALBUMIN (BCG) REAGENT SET | CIX | Substantially Equivalent | |
| K855164 | ENZYNATIC TRIGLYCERIDES REAGENT SET | CDT | Substantially Equivalent | |
| K860419 | UREA NITROGEN REAGENT SET | CDW | Substantially Equivalent | |
| K860418 | CREATININE REAGENT SET | CGX | Substantially Equivalent | |
| K860351 | ALKALINE PHOSPHATASE REAGENT SET | CIO | Substantially Equivalent | |
| K860341 | TOTAL PROTEIN (BIURET) REAGENT SET | CEK | Substantially Equivalent | |
| K860215 | MAGNESIUM REAGENT SET | JGJ | Substantially Equivalent | |
| K860142 | URIC ACID REAGENT SET (COLORIMETRIC) | LFQ | Substantially Equivalent | |
| K860096 | CPK REAGENT SET (COLORIMETRIC) | CGS | Substantially Equivalent | |
| K860044 | CALCIUM (CPC) REAGENT SET | CIC | Substantially Equivalent | |
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | CDL | Substantially Equivalent | |
| K855028 | TOTAL CHOLESTEROL REAGENT SET | CHH | Substantially Equivalent | |
| K854335 | GLUCOSE REAGENT SET (GOD/TRINDER) | CGA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- LFQAcid, Uric, Acid Reduction Of Ferric Ion
- KNKAcid, Uric, Uricase (Colorimetric)
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJAAmyloclastic, Amylase
- CDLBerthelot Indophenol, Urea Nitrogen
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JNTChromatographic, Phospholipids
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- DKJColorimetry, Salicylate
- CICCresolphthalein Complexone, Calcium
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CIGDiazo Colorimetry, Bilirubin
- CIQDiazo, Ast/Sgot
- JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CFGOil Emulsion/Thymolphthalein (Titrimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- GHMTest, Sickle Cell
- CEJTetraphenyl Borate, Colorimetry, Potassium
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- CEIUranyl Acetate/Zinc Acetate, Sodium
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- KHGWhole Blood Hemoglobin Determination
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0937-2017 | Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0936-2017 | Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0935-2017 | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0934-2017 | Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0933-2017 | Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0932-2017 | Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0931-2017 | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0930-2017 | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated | |
| Z-0929-2017 | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain