K902382 is an FDA 510(k) clearance for the C3C AND C4 RID KITS. This device is classified as a Complement C3, Antigen, Antiserum, Control (Class II - Special Controls, product code CZW).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on September 7, 1990, 100 days after receiving the submission on May 30, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K902382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1990 |
| Decision Date | September 07, 1990 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CZW — Complement C3, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |