The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Creatine Kinase (ck) Test Item #65411.
| Device ID | K924704 |
| 510k Number | K924704 |
| Device Name: | CREATINE KINASE (CK) TEST ITEM #65411 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner 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 | 1992-09-17 |
| Decision Date | 1992-10-13 |