K021757 is an FDA 510(k) clearance for the CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Good Biotech Corp. (Taichung, TW). The FDA issued a Cleared decision on July 29, 2002, 61 days after receiving the submission on May 29, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K021757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2002 |
| Decision Date | July 29, 2002 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |