Submission Details
| 510(k) Number | K060157 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 2006 |
| Decision Date | May 25, 2006 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
May 2006
Decision
125d
Days
Class 2
Risk
About This 510(k) Submission
K060157 is an FDA 510(k) clearance for the IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA, 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 May 25, 2006, 125 days after receiving the submission on January 20, 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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