Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GLZ · Predicate Candidate Screening

18 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

146 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K924882	TOXOPLASMA IGM IFA TEST SYSTEM	Zeus Scientific, Inc.	1993-03-23	176
K880007	TOXO IGM TEST	Gull Laboratories, Inc.	1988-03-17	73
K850591	FIAX TOXO-M ANTIBODIES TEST KIT	Intl. Diagnostic Technology	1985-04-30	75
K844287	ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII	Apple Diagnostic Products	1985-01-07	63
K842664	ANTI-TOXOPLASMA GONDII KIT	Amico Lab, Inc.	1984-08-28	49
K832900	IMMUNOENZYME TEST SYS-DETECT-IGM ANTI	Bionetic Laboratory Products	1983-11-14	77
K830869	POLYCHACO INDIRECT IMMUNOFLUORESCENCE	Parasitic Disease Consultants	1983-08-11	146
K811562	TOXOPLASMOSIS TEST KIT	Immuno-Diagnostic Products, Inc.	1981-07-16	43
K803134	TOXOPLASMA GONDII SEROLOGICAL REAGENTS	Microbiological Research Corp.	1981-01-29	48
K801720	TOXO BIO-BEAD TITRATION KIT	Litton Bionetics	1980-09-16	55
K791618	TORCH BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	85
K791611	TOXO BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	84
K791571	TOXOPLASMA ANTIBODY TEST SYSTEM	Zeus Scientific, Inc.	1979-09-24	42
K790464	FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO	Intl. Diagnostic Technology	1979-06-13	100
K790360	QUANTAZYME TOXOPLASMA	Bio-Rad	1979-05-22	89
K781549	TOXELISA TEST KIT	Microbiological Assoc.	1978-12-07	86
K780352	IMMUNOZYME TOXOPLASMA ANTIBODY	Millipore Corp.	1978-06-28	117
K772243	TOXO TEST	Gull Laboratories, Inc.	1977-12-22	14

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda