King Diagnostics, Inc.
Walker, MI, US
King Diagnostics, Inc. appears in FDA device records in Walker, MI. FDA records list 41 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 41
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 41 510(k) clearances for King Diagnostics, Inc. between 1981 and 1993. The busiest year on record is 1981, with 13. The most recent is 1993, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 13 |
| 1982 | 1 |
| 1983 | 1 |
| 1986 | 3 |
| 1988 | 6 |
| 1991 | 2 |
| 1992 | 11 |
| 1993 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | JMO | Substantially Equivalent | |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | JIS | Substantially Equivalent | |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | LBR | Substantially Equivalent | |
| K931326 | KING DIAGNOSTICS CK REAGENT | CGS | Substantially Equivalent | |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | CFR | Substantially Equivalent | |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | CDN | Substantially Equivalent | |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | CHJ | Substantially Equivalent | |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | JPZ | Substantially Equivalent | |
| K922964 | KING DIAGNOSTIC TRIGLYCERIDES REAGENT | CDT | Substantially Equivalent | |
| K922835 | CALCIUM (AZ III) REAGENT | CJY | Substantially Equivalent | |
| K922108 | KING DIAGNOSTICS AST (GOT) REAGENT | CIT | Substantially Equivalent | |
| K922109 | KING DIAGNOSTICS ALT (GPT) REAGENT | CKA | Substantially Equivalent | |
| K920809 | KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD | JIS | Substantially Equivalent | |
| K912499 | KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST | CHH | Substantially Equivalent | |
| K912251 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST | CFR | Substantially Equivalent | |
| K884485 | KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT | GFO | Substantially Equivalent | |
| K883640 | KD ONE-STAGE PROTHROMBIN TIME TEST | JPA | Substantially Equivalent | |
| K883637 | KD 0.02 M CALCIUM CHLORIDE SOLUTION | JPA | Substantially Equivalent | |
| K883635 | KD 0.1 M SODIUM CITRATE SOLUTION | JPA | Substantially Equivalent | |
| K882220 | CALIBRATION KIT | JIW | Substantially Equivalent | |
| K873726 | ACID PHOSPHATASE TEST | CKE | Substantially Equivalent | |
| K862498 | ALKALINE PHOSPHATASE TEST | CJE | Substantially Equivalent | |
| K862306 | KING DIAGNOSTICS LDH TEST | CFJ | Substantially Equivalent | |
| K862208 | KING DIAGNOSTICS URIC ACID TEST | KNK | Substantially Equivalent | |
| K831411 | GLUCOSE OXIDASE/PEROXIDASE TEST | CGA | Substantially Equivalent | |
| K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST | JGZ | Substantially Equivalent | |
| K812127 | KING DIAGNOSTICS HEMOGLOBIN TEST | GKR | Substantially Equivalent | |
| K811883 | KING DIAGNOSTICS GLUCOSE-O TEST | CGE | Substantially Equivalent | |
| K811882 | KING DIAGNOSTICS GLUCOSE TEST | CGA | Substantially Equivalent | |
| K811881 | KING DIAGNOSTICS TOTAL BILIRUBIN TEST | CIG | Substantially Equivalent | |
| K811749 | KING DIAGNOSTICS PHOSPHORUS TEST | CEO | Substantially Equivalent | |
| K811748 | KING DIAGNOSTICS CALCIUM TEST | CIC | Substantially Equivalent | |
| K811747 | KING DIAGNOSTICS CHOLESTEROL TEST | CGO | Substantially Equivalent | |
| K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST | CHO | Substantially Equivalent | |
| K811687 | URIC ACID TEST | KNK | Substantially Equivalent | |
| K811673 | TOTAL PROTEIN TEST | CEK | Substantially Equivalent | |
| K811664 | CREATININE TEST | CGX | Substantially Equivalent | |
| K811662 | ALBUMIN TEST | CIX | Substantially Equivalent | |
| K811661 | POTASSIUM TEST | CEJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- KNKAcid, Uric, Uricase (Colorimetric)
- GFOActivated Partial Thromboplastin
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JISCalibrator, Primary
- JIWCalibrator, Surrogate
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- 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
- JGZO-Phthalaldehyde, Urea Nitrogen
- CGEOrthotoluidine, Glucose
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CHORadioimmunoassay, Cyclic Amp
- GKRSystem, Hemoglobin, Automated
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- CEJTetraphenyl Borate, Colorimetry, Potassium
- CDNUrease, Photometric, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain