K904312 is an FDA 510(k) clearance for the RHEUMAGEN CRP T-CONTROL. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK).
Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on October 1, 1990, 12 days after receiving the submission on September 19, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K904312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1990 |
| Decision Date | October 01, 1990 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5270 |