K955042 is an FDA 510(k) clearance for the CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on December 13, 1995, 40 days after receiving the submission on November 3, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K955042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1995 |
| Decision Date | December 13, 1995 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |