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510(k) K880679

BION CMV-G TEST SYSTEM by Bion Ent., Ltd. — Product Code GQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1988
Date Received
February 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
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)
  • K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (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)

Other clearances for product code GQH

  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (May 5, 1994)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)
  • K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG (August 3, 1988)
  • K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (August 1, 1988)
  • K880290 — MICROTRAK CMV CULTURE CONFIRMATION TEST (April 19, 1988)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)
  • K873114 — CYTOMEGALOVIRUS CONTROL SLIDES (September 25, 1987)
  • K864565 — MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (February 19, 1987)