K830714 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT. This device is classified as a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG).
Submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983, 29 days after receiving the submission on March 8, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K830714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1983 |
| Decision Date | April 06, 1983 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1110 |