The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem - E-ckmb Immunoenzymetric Assay.
| Device ID | K832139 |
| 510k Number | K832139 |
| Device Name: | TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | HYBRITECH, INC. 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 | 1983-06-27 |
| Decision Date | 1983-08-12 |