K010148 is an FDA 510(k) clearance for the ENA SCREEN EIA KIT. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 23, 2001, 37 days after receiving the submission on January 17, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K010148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2001 |
| Decision Date | February 23, 2001 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |