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510(k) K070206

DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 by Diagnostic Hybrids, Inc. — Product Code GQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2007
Date Received
January 22, 2007
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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Other clearances for product code GQW

  • 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)
  • 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)