The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ria-quant Ck-mb Test Kit.
| Device ID | K792504 |
| 510k Number | K792504 |
| Device Name: | RIA-QUANT CK-MB TEST KIT |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-04 |
| Decision Date | 1980-01-16 |