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510(k) K894626

EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN by Bion Ent., Ltd. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Bion Ent., Ltd.

  • K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM (June 15, 1993)
  • K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE (April 5, 1990)
  • K894622 — VARICELLA ZOSTER VIRUS (October 24, 1989)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K894624 — MUMPS VIRUS (October 16, 1989)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K894625 — CHLAMYDIA (LGV-1) (August 15, 1989)
  • K893240 — BION EBV-M (VCA) TEST SYSTEM (July 14, 1989)
  • K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE (February 17, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)

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  • K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME L (January 11, 1999)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)