The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Creatine Kinase-sl Assay, Catalogue Number 326-10, 326-30.
| Device ID | K973999 |
| 510k Number | K973999 |
| Device Name: | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| 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 | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1998-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401079 | K973999 | 000 |
| 00628063400386 | K973999 | 000 |