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510(k) K880007

TOXO IGM TEST by Gull Laboratories, Inc. — Product Code GLZ

K880007 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "TOXO IGM TEST". The FDA issued a decision of Substantially Equivalent on March 17, 1988. The device falls under product code GLZ (Antigens, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1988
Date Received
January 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, If, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
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 GLZ

  • K924882 — TOXOPLASMA IGM IFA TEST SYSTEM (March 23, 1993)
  • K850591 — FIAX TOXO-M ANTIBODIES TEST KIT (April 30, 1985)
  • K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII (January 7, 1985)
  • K842664 — ANTI-TOXOPLASMA GONDII KIT (August 28, 1984)
  • K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (November 14, 1983)
  • K830869 — POLYCHACO INDIRECT IMMUNOFLUORESCENCE (August 11, 1983)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS (January 29, 1981)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K791618 — TORCH BIO-BEAD SCREEN KIT (November 13, 1979)

FDA data resources