K002674 is an FDA 510(k) clearance for the RANDOX MICROALBUMIN. This device is classified as a Albumin, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DDZ).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on October 5, 2000, 38 days after receiving the submission on August 28, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5040.
| 510(k) Number | K002674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2000 |
| Decision Date | October 05, 2000 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DDZ — Albumin, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5040 |