The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Aspartate Aminotransferase-sl Assay, Catalogue Number 319-10, 319-30.
| Device ID | K974001 |
| 510k Number | K974001 |
| Device Name: | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1997-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400157 | K974001 | 000 |
| 00628063400140 | K974001 | 000 |