Submission Details
| 510(k) Number | K091520 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 22, 2009 |
| Decision Date | March 10, 2010 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
Mar 2010
Decision
292d
Days
Class 2
Risk
About This 510(k) Submission
K091520 is an FDA 510(k) clearance for the IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 10, 2010, 292 days after receiving the submission on May 22, 2009. 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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