K030238 is an FDA 510(k) clearance for the BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT. This device is classified as a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBM).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on March 24, 2003, 60 days after receiving the submission on January 23, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090.
| 510(k) Number | K030238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2003 |
| Decision Date | March 24, 2003 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5090 |