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510(k) K853540

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY by Idt, A Division of Whittaker M.A. Bioproducts — Product Code GQX

K853540 is an FDA 510(k) premarket notification submitted by Idt, A Division of Whittaker M.A. Bioproducts for the device "FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY". The FDA issued a decision of Substantially Equivalent on February 4, 1986. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Idt, A Division of Whittaker M.A. Bioproducts has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1986
Date Received
August 23, 1985
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 Idt, A Division of Whittaker M.A. Bioproducts

  • K853067 — FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (October 22, 1985)
  • K782041 — FIAX TEST KIT (January 3, 1979)
  • K772219 — FIAX TEST FOR ANTI-RUBELLA ANTIBODY (January 20, 1978)
  • K772114 — FIAX C4 ASSAY (November 30, 1977)

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)
  • 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