K053090 is an FDA 510(k) clearance for the DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR. This device is classified as a Enzymatic Method, Bilirubin (Class II - Special Controls, product code JFM).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 16, 2005, 44 days after receiving the submission on November 2, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K053090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2005 |
| Decision Date | December 16, 2005 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFM — Enzymatic Method, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |