K981632 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Roche Diagnostics/Boehringer Mannheim GmbH (Indianapolis, US). The FDA issued a Cleared decision on June 15, 1998, 38 days after receiving the submission on May 8, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K981632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1998 |
| Decision Date | June 15, 1998 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |