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510(k) K042680

RHIGENE HEP-ANA TEST SYSTEM by Corgenix, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2004
Date Received
September 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • 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)

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  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
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