Submission Details
| 510(k) Number | K130528 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 2013 |
| Decision Date | October 21, 2013 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
BIOPLEX 2200 APLS IGM
Oct 2013
Decision
234d
Days
Class 2
Risk
About This 510(k) Submission
K130528 is an FDA 510(k) clearance for the BIOPLEX 2200 APLS IGM, 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 October 21, 2013, 234 days after receiving the submission on March 1, 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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