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510(k) K790106

IIF-A-N-DNA TEST KIT by Medica Corp. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1979
Date Received
January 18, 1979
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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  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K930421 — ELIAS DSDNA ABS (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)