Submission Details
| 510(k) Number | K083052 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 14, 2008 |
| Decision Date | July 28, 2009 |
| Days to Decision | 287 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
Jul 2009
Decision
287d
Days
Class 2
Risk
About This 510(k) Submission
K083052 is an FDA 510(k) clearance for the EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA), a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on July 28, 2009, 287 days after receiving the submission on October 14, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.
Device Classification
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5750 |
Manufacturer
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