Submission Details
| 510(k) Number | K091845 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 22, 2009 |
| Decision Date | June 07, 2010 |
| Days to Decision | 350 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
Jun 2010
Decision
350d
Days
Class 2
Risk
About This 510(k) Submission
K091845 is an FDA 510(k) clearance for the CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM, 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 June 7, 2010, 350 days after receiving the submission on June 22, 2009. 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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