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510(k) K130528

BIOPLEX 2200 APLS IGM by Bio-Rad Laboratories — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2013
Date Received
March 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Anticardiolipin Immunological
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)
  • K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (March 30, 2012)
  • K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (December 12, 2011)
  • K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (June 7, 2010)
  • K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (March 11, 2010)
  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)
  • K040463 — AESKULISA CARDIOLIPIN AGM (May 12, 2004)