K964985 is an FDA 510(k) clearance for the QUANTA LITE IGG GLIADIN ELISA. 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 May 30, 1997, 168 days after receiving the submission on December 13, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K964985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1996 |
| Decision Date | May 30, 1997 |
| Days to Decision | 168 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 |