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510(k) K903882

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG by Viral Antigens, Inc. — Product Code GQW

K903882 is an FDA 510(k) premarket notification submitted by Viral Antigens, Inc. for the device "VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG". The FDA issued a decision of Substantially Equivalent on December 4, 1990. The device falls under product code GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Viral Antigens, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1990
Date Received
August 22, 1990
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 Viral Antigens, Inc.

  • K964874 — HSV-1 ANTIGEN CONTROL SLIDES (July 1, 1997)
  • K971101 — HSV-2 ANTIGEN CONTROL SLIDES (July 1, 1997)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K964872 — VZV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K964870 — RSV ANTIGEN CONTROL SLIDES (March 18, 1997)

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)
  • 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)

FDA data resources