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510(k) K912239

VZVSCAN(TM) LATEX AGGUTINATION TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1991
Date Received
May 21, 1991
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

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  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
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  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
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  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code GQW

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  • 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)
  • K903882 — VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (December 4, 1990)
  • K894622 — VARICELLA ZOSTER VIRUS (October 24, 1989)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K841434 — VARICELLA-ZOSTER(IGG) IFA TEST (April 19, 1985)
  • K802938 — VARICELLA-ZOSTER ANTIGENS & CONTROLS (December 31, 1980)