K000661 is an FDA 510(k) clearance for the RANDOX PREALBUMIN. This device is classified as a Prealbumin, Antigen, Antiserum, Control (Class I - General Controls, product code JZJ).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on April 13, 2000, 45 days after receiving the submission on February 28, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5060.
| 510(k) Number | K000661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2000 |
| Decision Date | April 13, 2000 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JZJ — Prealbumin, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5060 |