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510(k) K001352

REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT by Corgenix, Inc. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2001
Date Received
April 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Systemic Lupus Erythematosus
Device Class
Class II
Regulation Number
866.5820
Review Panel
IM
Submission Type

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  • 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)
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  • K022990 — REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 (September 25, 2002)

Other clearances for product code DHC

  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • K930421 — ELIAS DSDNA ABS (March 10, 1993)
  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K821385 — SERO/TEX LE TEST (May 28, 1982)
  • K810981 — ANTI NDNA IMMUNOFLOURESCENT TEST SYS (April 29, 1981)
  • K810226 — SLE ANTI-N-DNA LATEX TEST (February 9, 1981)
  • K800992 — CORDIA NP (May 8, 1980)