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510(k) K901156

EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM by Granbio, Inc. — Product Code GNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
March 13, 1990
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 Granbio, Inc.

  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K934774 — UNKNOWN (April 20, 1994)
  • K901840 — (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (June 7, 1988)
  • K871298 — EBNA ACIF ASSAY KIT (June 25, 1987)
  • K864347 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA (February 2, 1987)
  • K864604 — EBV VCA IGM ANTIBODY ASSAY KIT (February 2, 1987)

Other clearances for product code GNP

  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)
  • 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)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K880885 — EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (August 30, 1988)
  • K880883 — EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (August 30, 1988)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)