K892231 is an FDA 510(k) clearance for the V-TREND TARGET CRP TEST. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on April 21, 1989, 17 days after receiving the submission on April 4, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K892231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1989 |
| Decision Date | April 21, 1989 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |