K990207 is an FDA 510(k) clearance for the GLIADIN IGA ELISA TEST SYSTEM. This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on March 26, 1999, 64 days after receiving the submission on January 21, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K990207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1999 |
| Decision Date | March 26, 1999 |
| Days to Decision | 64 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 |