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510(k) K802938

VARICELLA-ZOSTER ANTIGENS & CONTROLS by Orion Diagnostica, Inc. — Product Code GQW

K802938 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "VARICELLA-ZOSTER ANTIGENS & CONTROLS". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1980
Date Received
November 19, 1980
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 Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 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)
  • K894622 — VARICELLA ZOSTER VIRUS (October 24, 1989)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K841434 — VARICELLA-ZOSTER(IGG) IFA TEST (April 19, 1985)

FDA data resources