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510(k) K983914

REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT by Corgenix, Inc. — Product Code GGP

K983914 is an FDA 510(k) premarket notification submitted by Corgenix, Inc. for the device "REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Corgenix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
November 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances by Corgenix, Inc.

  • K072032 — IGG ANTI-ATHEROX TEST KIT (April 4, 2008)
  • 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)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)

FDA data resources