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510(k) K072032

IGG ANTI-ATHEROX TEST KIT by Corgenix, Inc. — Product Code MSV

K072032 is an FDA 510(k) premarket notification submitted by Corgenix, Inc. for the device "IGG ANTI-ATHEROX TEST KIT". The FDA issued a decision of Substantially Equivalent on April 4, 2008. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Corgenix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2008
Date Received
July 24, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Corgenix, Inc.

  • K062025 — ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 (May 29, 2007)
  • 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)
  • K024195 — MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE 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 MSV

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (June 25, 2018)
  • K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody (June 19, 2017)
  • K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar (December 21, 2015)
  • K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTRO (February 13, 2015)
  • K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (June 22, 2012)
  • K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (May 21, 2010)
  • K092757 — THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (October 9, 2009)
  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)
  • K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (May 11, 2004)

FDA data resources