K082141 is an FDA 510(k) clearance for the ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on September 3, 2008, 35 days after receiving the submission on July 30, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K082141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2008 |
| Decision Date | September 03, 2008 |
| Days to Decision | 35 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |