The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Ck-mb(immunological).
| Device ID | K802521 |
| 510k Number | K802521 |
| Device Name: | CK-MB(IMMUNOLOGICAL) |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | BIODYNAMICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-11-12 |