The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Creatine Kinase-mb Kit.
| Device ID | K820812 |
| 510k Number | K820812 |
| Device Name: | CREATINE KINASE-MB KIT |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-23 |
| Decision Date | 1982-04-12 |