K973995 is an FDA 510(k) clearance for the RANDOX BILIRUBIN. This device is classified as a Hemoglobinometer (Class II - Special Controls, product code GIG).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on December 8, 1997, 48 days after receiving the submission on October 21, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7500.
| 510(k) Number | K973995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1997 |
| Decision Date | December 08, 1997 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | GIG — Hemoglobinometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7500 |