Submission Details
| 510(k) Number | K113020 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 11, 2011 |
| Decision Date | October 25, 2012 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
Oct 2012
Decision
380d
Days
Class 2
Risk
About This 510(k) Submission
K113020 is an FDA 510(k) clearance for the IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 25, 2012, 380 days after receiving the submission on October 11, 2011. 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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