Submission Details
| 510(k) Number | K032571 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 20, 2003 |
| Decision Date | December 24, 2003 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
Dec 2003
Decision
126d
Days
Class 2
Risk
About This 510(k) Submission
K032571 is an FDA 510(k) clearance for the IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA 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 December 24, 2003, 126 days after receiving the submission on August 20, 2003. 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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