K040241 is an FDA 510(k) clearance for the N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on June 25, 2004, 143 days after receiving the submission on February 3, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K040241 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2004 |
| Decision Date | June 25, 2004 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |