K896272 is an FDA 510(k) clearance for the QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on November 8, 1989, 9 days after receiving the submission on October 30, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K896272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1989 |
| Decision Date | November 08, 1989 |
| Days to Decision | 9 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 |