The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Alanine Aminotransferase-sl Assay Catalogue Number 318-10, 318-30.
| Device ID | K974003 |
| 510k Number | K974003 |
| Device Name: | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1997-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400119 | K974003 | 000 |
| 00628063400102 | K974003 | 000 |