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510(k) K803134

TOXOPLASMA GONDII SEROLOGICAL REAGENTS by Microbiological Research Corp. — Product Code GLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1981
Date Received
December 12, 1980
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 Microbiological Research Corp.

  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • K843138 — CMV TEST (January 29, 1985)
  • K821018 — ANTIHUMAN IGG GLOBULIN FITC LABELED (April 29, 1982)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K803133 — RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL (January 29, 1981)

Other clearances for product code GLZ

  • K924882 — TOXOPLASMA IGM IFA TEST SYSTEM (March 23, 1993)
  • K880007 — TOXO IGM TEST (March 17, 1988)
  • 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)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K791618 — TORCH BIO-BEAD SCREEN KIT (November 13, 1979)