The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Ck-mb Assay, Catalogue Number 317-10.
| Device ID | K942773 |
| 510k Number | K942773 |
| Device Name: | CK-MB ASSAY, CATALOGUE NUMBER 317-10 |
| 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 | 1994-06-13 |
| Decision Date | 1994-08-24 |