K000468 is an FDA 510(k) clearance for the RANDOX COMPLEMENT C4. This device is classified as a Complement C4, Antigen, Antiserum, Control (Class II - Special Controls, product code DBI).
Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on March 27, 2000, 45 days after receiving the submission on February 11, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K000468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2000 |
| Decision Date | March 27, 2000 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBI — Complement C4, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |