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510(k) K001398

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2001
Date Received
May 3, 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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Other clearances for product code DHC

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  • 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)
  • K800991 — CORDIA N (May 8, 1980)