K832094 is an FDA 510(k) clearance for the BILIRUBIN CALIBRATORS & CONTROL. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983, 44 days after receiving the submission on June 28, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K832094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1983 |
| Decision Date | August 11, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |