Tech Intl. Co.
Medical device manufacturer in Placentia, CA.
13510(k) clearances
0PMA approvals
0recalls
Device types
- CEI Uranyl Acetate/Zinc Acetate, Sodium 1
- CKB Acid Phosphatase, Naphthyl Phosphate 1
- DIH Colorimetry, Cholinesterase 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CGA Glucose Oxidase, Glucose 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- JFJ Catalytic Methods, Amylase 1
- CET Olive Oil Emulsion (Turbidimetric), Lipase 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- JIF Enzymatic Method, Ammonia 1
- CKE Acid Phosphatase, Thymolphthale… 1
- CJD Nitrosalicylate Reduction, Amylase 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K915704 | Amylase (Kinetic) Reagent SetCJD · Traditional | 06/28/1996SE |
| K915705 | Acid Phosphatase Reagent SetCKE · Traditional | 02/27/1992SE |
| K915707 | Ammonia Reagent SetJIF · Traditional | 02/26/1992SE |
| K914158 | Uric Acid Reagent SetKNK · Traditional | 02/21/1992SE |
| K915706 | Lipase Reagent SetCET · Traditional | 02/18/1992SE |
| K915710 | Amylase (Colorimetric) Reagent SetJFJ · Traditional | 01/30/1992SE |
| K914160 | Cholesterol Regeant SetCHH · Traditional | 01/30/1992SE |
| K915709 | Creatine Kinase-Mb (Ck-Mb) Reagent SetCGS · Traditional | 01/27/1992SE |
| K914159 | Glucose Reagent SetCGA · Traditional | 01/27/1992SE |
| K915708 | Inorganic Phosphorus(Colorimetric) Reagent SetCEO · Traditional | 01/22/1992SE |
| K914171 | In Vitro Diagnostic Regeant Set,CholinesteraseDIH · Traditional | 12/18/1991SE |
| K902495 | Acid Phosphatase Reagent SetCKB · Traditional | 07/16/1990SE |
| K902572 | Sodium Reagent SetCEI · Traditional | 07/10/1990SE |