Tech Intl. Co.
Rochester Hills, MI, US
Tech Intl. Co. appears in FDA device records in Rochester Hills, MI. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Tech Intl. Co. between 1990 and 1996. The busiest year on record is 1992, with 9. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 9 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K915704 | AMYLASE (KINETIC) REAGENT SET | CJD | Substantially Equivalent | |
| K915705 | ACID PHOSPHATASE REAGENT SET | CKE | Substantially Equivalent | |
| K915707 | AMMONIA REAGENT SET | JIF | Substantially Equivalent | |
| K914158 | URIC ACID REAGENT SET | KNK | Substantially Equivalent | |
| K915706 | LIPASE REAGENT SET | CET | Substantially Equivalent | |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | JFJ | Substantially Equivalent | |
| K914160 | CHOLESTEROL REGEANT SET | CHH | Substantially Equivalent | |
| K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | CGS | Substantially Equivalent | |
| K914159 | GLUCOSE REAGENT SET | CGA | Substantially Equivalent | |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | CEO | Substantially Equivalent | |
| K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | DIH | Substantially Equivalent | |
| K902495 | ACID PHOSPHATASE REAGENT SET | CKB | Substantially Equivalent | |
| K902572 | SODIUM REAGENT SET | CEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- KNKAcid, Uric, Uricase (Colorimetric)
- JFJCatalytic Methods, Amylase
- DIHColorimetry, Cholinesterase
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JIFEnzymatic Method, Ammonia
- CGAGlucose Oxidase, Glucose
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CJDNitrosalicylate Reduction, Amylase
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CEIUranyl Acetate/Zinc Acetate, Sodium
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain