Submission Details
| 510(k) Number | K163177 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2016 |
| Decision Date | July 28, 2017 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
Jul 2017
Decision
256d
Days
Class 2
Risk
About This 510(k) Submission
K163177 is an FDA 510(k) clearance for the ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on July 28, 2017, 256 days after receiving the submission on November 14, 2016. 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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