Submission Details
| 510(k) Number | K103834 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 2010 |
| Decision Date | March 30, 2012 |
| Days to Decision | 456 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
Mar 2012
Decision
456d
Days
Class 2
Risk
About This 510(k) Submission
K103834 is an FDA 510(k) clearance for the BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on March 30, 2012, 456 days after receiving the submission on December 30, 2010. 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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