Atlas FDA

GLZ

18 FDA 510(k) clearances · Product code

77 daysmedian time to decision
146 days90th percentile
18clearances measured

FDA profile

Official device name
Antigens, If, Toxoplasma Gondii
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3780
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
TOXOPLASMA IGM IFA TEST SYSTEM (K924882)Zeus Scientific, Inc.1993-03-23
TOXO IGM TEST (K880007)Gull Laboratories, Inc.1988-03-17
FIAX TOXO-M ANTIBODIES TEST KIT (K850591)Intl. Diagnostic Technology1985-04-30
ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII (K844287)Apple Diagnostic Products1985-01-07
ANTI-TOXOPLASMA GONDII KIT (K842664)Amico Lab, Inc.1984-08-28
IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (K832900)Bionetic Laboratory Products1983-11-14
POLYCHACO INDIRECT IMMUNOFLUORESCENCE (K830869)Parasitic Disease Consultants1983-08-11
TOXOPLASMOSIS TEST KIT (K811562)Immuno-Diagnostic Products, Inc.1981-07-16
TOXOPLASMA GONDII SEROLOGICAL REAGENTS (K803134)Microbiological Research Corp.1981-01-29
TOXO BIO-BEAD TITRATION KIT (K801720)Litton Bionetics1980-09-16
TORCH BIO-BEAD SCREEN KIT (K791618)Litton Bionetics1979-11-13
TOXO BIO-BEAD SCREEN KIT (K791611)Litton Bionetics1979-11-13
TOXOPLASMA ANTIBODY TEST SYSTEM (K791571)Zeus Scientific, Inc.1979-09-24
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO (K790464)Intl. Diagnostic Technology1979-06-13
QUANTAZYME TOXOPLASMA (K790360)Bio-Rad1979-05-22
TOXELISA TEST KIT (K781549)Microbiological Assoc.1978-12-07
IMMUNOZYME TOXOPLASMA ANTIBODY (K780352)Millipore Corp.1978-06-28
TOXO TEST (K772243)Gull Laboratories, Inc.1977-12-22

Track GLZ automatically

Every clearance here is in the API, with alerts when new ones post.