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510(k) K024195

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT by Corgenix, Inc. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2003
Date Received
December 20, 2002
Clearance Type
Special
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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  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)
  • K032139 — REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 (April 5, 2004)
  • K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (January 8, 2004)
  • K032868 — REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 (October 14, 2003)
  • K031208 — REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 (July 7, 2003)
  • K024196 — REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (January 3, 2003)
  • K022990 — REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 (September 25, 2002)
  • K022992 — REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 (September 25, 2002)

Other clearances for product code MID

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  • K130528 — BIOPLEX 2200 APLS IGM (October 21, 2013)
  • K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (February 26, 2013)
  • 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)