The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Aspartate Aminotransferase Assay Kit (ifcc).
| Device ID | K880692 |
| 510k Number | K880692 |
| Device Name: | ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Callbeck, R.t. |
| Correspondent | Callbeck, R.t. DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-05-27 |