The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ck-mb (creatine Kinase-mb) Ria Control.
| Device ID | K792524 |
| 510k Number | K792524 |
| Device Name: | CK-MB (CREATINE KINASE-MB) RIA CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-06 |
| Decision Date | 1980-01-16 |