The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ria-quant Fpa Test Kit.
| Device ID | K821151 |
| 510k Number | K821151 |
| Device Name: | RIA-QUANT FPA TEST KIT |
| Classification | Fibrinopeptide A, Antigen, Antiserum, Control |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DAN |
| CFR Regulation Number | 866.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-26 |
| Decision Date | 1982-07-22 |