Submission Details
| 510(k) Number | K091522 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 22, 2009 |
| Decision Date | February 04, 2010 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
Feb 2010
Decision
258d
Days
Class 2
Risk
About This 510(k) Submission
K091522 is an FDA 510(k) clearance for the IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on February 4, 2010, 258 days after receiving the submission on May 22, 2009. 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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