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510(k) K951799

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY by Light Diagnostics — Product Code GQX

K951799 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on March 20, 1996. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Light Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1996
Date Received
April 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
Review Panel
MI
Submission Type

Other clearances by Light Diagnostics

  • K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (November 9, 1999)
  • K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (October 19, 1999)
  • K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT (December 22, 1998)
  • K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (April 8, 1998)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (September 8, 1995)
  • K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (September 8, 1995)

Other clearances for product code GQX

  • K911301 — VZV IGM TEST (July 17, 1991)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K875358 — VZV TEST (March 31, 1988)
  • K863317 — ENZYGNOST ANTI-VZV IGG TEST (April 22, 1987)
  • K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (February 4, 1986)
  • K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (November 12, 1985)
  • K842096 — GLB VARICELLA-ZOSTER VIRUS FLUORESCENT (January 7, 1985)
  • K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT. (June 25, 1984)
  • K770810 — VARICELLA-ZOSTER FA LABELED PRESERUM (May 20, 1977)
  • K770806 — VARICELLA-ZOSTER FA LABELLED (8-321 RF) (May 20, 1977)

FDA data resources