K070083 is an FDA 510(k) clearance for the QUANTA LITE H-TTG/DGP SCREEN. 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 March 12, 2007, 62 days after receiving the submission on January 9, 2007.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K070083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2007 |
| Decision Date | March 12, 2007 |
| Days to Decision | 62 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 |