Submission Details
| 510(k) Number | K062583 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 01, 2006 |
| Decision Date | December 26, 2006 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
Dec 2006
Decision
116d
Days
Class 2
Risk
About This 510(k) Submission
K062583 is an FDA 510(k) clearance for the ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on December 26, 2006, 116 days after receiving the submission on September 1, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.
Device Classification
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
Manufacturer
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