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510(k) K842096

GLB VARICELLA-ZOSTER VIRUS FLUORESCENT by Great Lakes Bioscience — Product Code GQX

K842096 is an FDA 510(k) premarket notification submitted by Great Lakes Bioscience for the device "GLB VARICELLA-ZOSTER VIRUS FLUORESCENT". The FDA issued a decision of Substantially Equivalent on January 7, 1985. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1985
Date Received
May 25, 1984
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 for product code GQX

  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • 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)
  • K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT. (June 25, 1984)
  • K770806 — VARICELLA-ZOSTER FA LABELLED (8-321 RF) (May 20, 1977)
  • K770810 — VARICELLA-ZOSTER FA LABELED PRESERUM (May 20, 1977)

FDA data resources