Company ยท US
Tech Intl. Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1996. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEI | Uranyl Acetate/Zinc Acetate, Sodium | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CJD | Nitrosalicylate Reduction, Amylase | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 |
| CKE | Acid Phosphatase, Thymolphthale Inmonophosphate | 1 |
| DIH | Colorimetry, Cholinesterase | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JIF | Enzymatic Method, Ammonia | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 28, 1996 | K915704 | AMYLASE (KINETIC) REAGENT SET Tech Intl. Co. | CJD |
| Feb 27, 1992 | K915705 | ACID PHOSPHATASE REAGENT SET Tech Intl. Co. | CKE |
| Feb 26, 1992 | K915707 | AMMONIA REAGENT SET Tech Intl. Co. | JIF |
| Feb 21, 1992 | K914158 | URIC ACID REAGENT SET Tech Intl. Co. | KNK |
| Feb 18, 1992 | K915706 | LIPASE REAGENT SET Tech Intl. Co. | CET |
| Jan 30, 1992 | K915710 | AMYLASE (COLORIMETRIC) REAGENT SET Tech Intl. Co. | JFJ |
| Jan 30, 1992 | K914160 | CHOLESTEROL REGEANT SET Tech Intl. Co. | CHH |
| Jan 27, 1992 | K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET Tech Intl. Co. | CGS |
| Jan 27, 1992 | K914159 | GLUCOSE REAGENT SET Tech Intl. Co. | CGA |
| Jan 22, 1992 | K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET Tech Intl. Co. | CEO |
| Dec 18, 1991 | K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE Tech Intl. Co. | DIH |
| Jul 16, 1990 | K902495 | ACID PHOSPHATASE REAGENT SET Tech Intl. Co. | CKB |
| Jul 10, 1990 | K902572 | SODIUM REAGENT SET Tech Intl. Co. | CEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||