K052262 is an FDA 510(k) clearance for the QUANTA LITE M2 EP (MIT3) ELISA. This device is classified as a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBM).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 27, 2005, 69 days after receiving the submission on August 19, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090.
| 510(k) Number | K052262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2005 |
| Decision Date | October 27, 2005 |
| Days to Decision | 69 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 |