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510(k) K854207

EBV(EPSTEIN-BARR VIRUS) TEST KIT by Immuno-Diagnostic Products, Inc. — Product Code GNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1986
Date Received
October 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Immuno-Diagnostic Products, Inc.

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  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)

Other clearances for product code GNP

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  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (June 13, 2002)
  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K981831 — IS EBV-EA-D IGG ELISA TEST SYSTEM (February 16, 1999)
  • K981829 — IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (February 16, 1999)
  • K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K880883 — EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (August 30, 1988)
  • K880885 — EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (August 30, 1988)