Home / 510(k) Clearances / K911301

510(k) K911301

VZV IGM TEST by Gull Laboratories, Inc. — Product Code GQX

K911301 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "VZV IGM TEST". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
March 25, 1991
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 Gull Laboratories, Inc.

  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K971857 — MUMPS IGG ELISA TESTY (November 4, 1997)
  • K962343 — TOXO IGG ELISA TEST (March 24, 1997)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K940093 — EBV-EA(D) IGG ELISA TEST (September 15, 1995)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)
  • K941198 — EBV LGG ELISA TEST (August 23, 1995)
  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
  • K941624 — RUBELLA IGG ELISA TEST (August 4, 1995)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

Other clearances for product code GQX

  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • 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