The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Emds Creatine Kinase Item Nimber 65411.
| Device ID | K893691 |
| 510k Number | K893691 |
| Device Name: | EMDS CREATINE KINASE ITEM NIMBER 65411 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna Bentley |
| Correspondent | Anna Bentley DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-16 |
| Decision Date | 1989-08-31 |