K141928 is an FDA 510(k) clearance for the COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on November 25, 2014, 132 days after receiving the submission on July 16, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K141928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2014 |
| Decision Date | November 25, 2014 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |