K934068 is an FDA 510(k) clearance for the BECKMAN DIRECT BILIRUBIN REAGENT. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on April 26, 1994, 249 days after receiving the submission on August 20, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K934068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1993 |
| Decision Date | April 26, 1994 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |