Submission Details
| 510(k) Number | K093459 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2009 |
| Decision Date | August 13, 2010 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
Aug 2010
Decision
280d
Days
Class 2
Risk
About This 510(k) Submission
K093459 is an FDA 510(k) clearance for the ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on August 13, 2010, 280 days after receiving the submission on November 6, 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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