The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Creatine Kinase Mb Test Item Number 5a46.
| Device ID | K914361 |
| 510k Number | K914361 |
| Device Name: | CREATINE KINASE MB TEST ITEM NUMBER 5A46 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G.bentley |
| Correspondent | Anna G.bentley EM DIAGNOSTIC SYSTEMS, INC. 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 | 1991-10-01 |
| Decision Date | 1991-12-13 |