K000483 is an FDA 510(k) clearance for the RANDOX ALBUMIN. This device is classified as a Bromcresol Purple Dye-binding, Albumin (Class II - Special Controls, product code CJW).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on March 31, 2000, 46 days after receiving the submission on February 14, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K000483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2000 |
| Decision Date | March 31, 2000 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CJW — Bromcresol Purple Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |