The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Ast/sgot Liquid Reagent - Kinetic Method.
| Device ID | K981650 |
| 510k Number | K981650 |
| Device Name: | AST/SGOT LIQUID REAGENT - KINETIC METHOD |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Rhoda Filipina |
| Correspondent | Rhoda Filipina TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1998-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001167 | K981650 | 000 |
| 10673486001150 | K981650 | 000 |
| 00850053916038 | K981650 | 000 |