Home / 510(k) Clearances / K964872

510(k) K964872

VZV ANTIGEN CONTROL SLIDES by Viral Antigens, Inc. — Product Code GQW

K964872 is an FDA 510(k) premarket notification submitted by Viral Antigens, Inc. for the device "VZV ANTIGEN CONTROL SLIDES". The FDA issued a decision of Substantially Equivalent on March 18, 1997. 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
March 18, 1997
Date Received
December 5, 1996
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)
  • K964870 — RSV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K903882 — VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (December 4, 1990)

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)
  • 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)

FDA data resources