K052143 is an FDA 510(k) clearance for the QUANTA LITE GLIADIN IGA II. This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 4, 2005, 57 days after receiving the submission on August 8, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K052143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2005 |
| Decision Date | October 04, 2005 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |