Submission Details
| 510(k) Number | K063775 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 21, 2006 |
| Decision Date | March 14, 2007 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
Mar 2007
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K063775 is an FDA 510(k) clearance for the ELIA GLIADIN IGA, IGG AND CELIAC CONTROL, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on March 14, 2007, 83 days after receiving the submission on December 21, 2006. 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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