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510(k) K020717

EBV V VCA IGM ELISA KIT MODEL# EBM-200 by Pan Bio Pty. , Ltd. — Product Code GNP

K020717 is an FDA 510(k) premarket notification submitted by Pan Bio Pty. , Ltd. for the device "EBV V VCA IGM ELISA KIT MODEL# EBM-200". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code GNP (Antiserum, Cf, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Pan Bio Pty. , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
March 5, 2002
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 Pan Bio Pty. , Ltd.

  • K021793 — EBV EA-D IGG ELISA KIT, MODEL EBG-100 (September 27, 2002)
  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)

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)
  • K981829 — IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (February 16, 1999)
  • K981831 — IS EBV-EA-D 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)
  • 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)

FDA data resources