K972160 is an FDA 510(k) clearance for the CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK).
Submitted by Trinity Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on August 1, 1997, 53 days after receiving the submission on June 9, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K972160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1997 |
| Decision Date | August 01, 1997 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5270 |