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510(k) K864347

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA by Granbio, Inc. — Product Code GNP

K864347 is an FDA 510(k) premarket notification submitted by Granbio, Inc. for the device "INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code GNP (Antiserum, Cf, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Granbio, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
November 4, 1986
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)
  • K901156 — EIA FOR IGG 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)
  • K864604 — EBV VCA IGM ANTIBODY ASSAY KIT (February 2, 1987)

Other clearances for product code GNP

  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)
  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (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)

FDA data resources