Submission Details
| 510(k) Number | K131821 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2013 |
| Decision Date | December 23, 2013 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
Dec 2013
Decision
186d
Days
Class 2
Risk
About This 510(k) Submission
K131821 is an FDA 510(k) clearance for the ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on December 23, 2013, 186 days after receiving the submission on June 20, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.
Device Classification
| Product Code | MID — System, Test, Anticardiolipin Immunological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
Manufacturer
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