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510(k) K894622

VARICELLA ZOSTER VIRUS by Bion Ent., Ltd. — Product Code GQW

K894622 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "VARICELLA ZOSTER VIRUS". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, (Including Cf Control), Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
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)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (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)

Other clearances for product code GQW

  • K070206 — DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (August 30, 2007)
  • K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (October 19, 1999)
  • K964872 — VZV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K942743 — VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT (December 15, 1994)
  • K912239 — VZVSCAN(TM) LATEX AGGUTINATION TEST (June 11, 1991)
  • K903882 — VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (December 4, 1990)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K841434 — VARICELLA-ZOSTER(IGG) IFA TEST (April 19, 1985)
  • K802938 — VARICELLA-ZOSTER ANTIGENS & CONTROLS (December 31, 1980)

FDA data resources