Tech-Co, Inc.
Oak Park, MI, US
Tech-Co, Inc. appears in FDA device records in Oak Park, MI. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Tech-Co, Inc. between 1987 and 1988. The busiest year on record is 1988, with 17. The most recent is 1988, with 17.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1988 | 17 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | CKD | Substantially Equivalent | |
| K883683 | HEMOGLOBIN | GJZ | Substantially Equivalent | |
| K883386 | CHLORIDE | CHJ | Substantially Equivalent | |
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | CIQ | Substantially Equivalent | |
| K881172 | BILIRUBIN (DIRECT) | CIG | Substantially Equivalent | |
| K881626 | GAMMA-GLUTAMYL TRANSFERASE | JQB | Substantially Equivalent | |
| K881171 | PHOSPHORUS (INORGANIC) | CEO | Substantially Equivalent | |
| K880177 | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | CIO | Substantially Equivalent | |
| K880629 | CREATININE | CGX | Substantially Equivalent | |
| K880630 | LACTATE DEHYDROGENASE (LDH-L) | CFH | Substantially Equivalent | |
| K880628 | TRIGLYCERIDES (GPO-TRINDER) | CDT | Substantially Equivalent | |
| K874846 | GLUCOSE (HEXOKINASE) | CFR | Substantially Equivalent | |
| K880178 | CREATINE KINASE (COLORIMETRIC METHOD) | JHY | Substantially Equivalent | |
| K880176 | HDL CHOLESTEROL PRECIPITATING REAGENT | LBR | Substantially Equivalent | |
| K875071 | ASPARTATE AMINOTRANSFERASE AST/SGOT | CIT | Substantially Equivalent | |
| K875070 | ALBUMIN, BROMCRESOL GREEN DYE-BINDING | CIX | Substantially Equivalent | |
| K875069 | BILIRUBIN (TOTAL) | CIG | Substantially Equivalent | |
| K874848 | LACTATE DEHYDROGENASE LDH-L | CFJ | Substantially Equivalent | |
| K874847 | MAGNESIUM | JGJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CIXBromcresol Green Dye-Binding, Albumin
- JHYColorimetric Method, Cpk Or Isoenzymes
- GJZCyanomethemoglobin Reagent And Standard Solution
- CIGDiazo Colorimetry, Bilirubin
- CIQDiazo, Ast/Sgot
- CFRHexokinase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
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