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

CGI · Predicate Candidate Screening

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

42 daysmedian FDA review time

84 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K974721	UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN	Bayer Corp.	1998-03-03	75
K962875	ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA	Diagnostic Systems Laboratories, Inc.	1996-08-23	30
K955356	ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL	Diagnostic Systems Laboratories, Inc.	1996-05-15	176
K932989	COAT-A-COUNT FREE ESTRIOL	Diagnostic Products Corp.	1994-12-19	549
K944490	AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT	Wallac OY	1994-12-09	87
K920576	AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL	Eastman Kodak Company	1992-03-23	42
K903359	MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT	Immunotech Corp.	1990-08-22	28
K860900	IMMPULSE FREE ESTRIOL ASSAY REAGENTS	Sclavo, Inc.	1986-04-28	49
K850787	SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY	Nms Pharmaceuticals, Inc.	1985-03-26	28
K844767	RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO	Biotecx Laboratories, Inc.	1985-02-01	56
K844511	TDX TOTAL ESTRIOL	Abbott Laboratories	1985-01-18	59
K844408	AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED	Amersham Corp.	1984-12-11	27
K840902	ENDAB ESTRIOL UNCONJUGATED	Immunotech Corp.	1984-04-18	50
K840301	RIANEN ESTRIOL RADIOIMMUNOASSAY KIT	New England Nuclear	1984-03-30	66
K830816	DSL 1900	Diagnostic Systems	1983-04-12	28
K823202	FREE & TOTAL ESTRIOL KIT	Diagnostic Products Corp.	1982-12-15	50
K822578	MICROMEDIC ESTRIOL RIA KIT	Micromedic Systems	1982-10-26	62
K822314	DSL 1400	Diagnostic Systems Laboratories, Inc.	1982-09-30	58
K821678	AUTOPAK ESTRIOL TEST DELIVERY SYSTEM	Micromedic Systems	1982-06-24	16
K820728	QUANTIMUNE ESTRIOL RIA	Bio-Rad	1982-04-06	20
K812768	COAT-A-COUNT FREE & TOTAL ESTRIOL KIT	Diagnostic Products Corp.	1982-01-18	105
K811709	QUANTIMUNE ESTRIOL RIA	Bio-Rad	1981-07-10	23
K811380	ESTRIOL KIT	Cambridge Nuclear Corp.	1981-06-09	25
K811371	NATAL-TEC ESTRIOL	Armkel, LLC	1981-05-29	15
K810667	AMERLEX ESTRIOL RIA KIT	Amersham Corp.	1981-03-31	19
K802754	IMMUNOREACTIVE ESTRIOL RIA KIT	Microanalytic Research, Inc.	1981-01-21	79
K802944	QUANTIMUNE E3 RIA	Bio-Rad	1980-12-22	33
K802455	ESTRIOL-SQUIBB RIA KIT	E. R. Squibb & Sons, Inc.	1980-10-31	23
K801735	ARIA II 125- I-ESTRIOL SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1980-09-16	53
K801424	ESTRIOL RIA KIT FOR USE WITH GAMMAFLO	Squibb & Sons, Inc.	1980-07-21	34
K800036	TOTAL ESTRIOL RIA KIT	Amersham Corp.	1980-01-21	14
K792189	NORDICLAB TOTAL ESTRIOL RIA TEST	Nordiclab Intl.	1979-11-13	13
K791728	RSL'S ASSAY PROCEDURE QUANTITATION	Radioassay Systems Laboratories, Inc.	1979-09-27	28
K790008	I ESTRIOL	Cambridge Nuclear Corp.	1979-02-26	55
K781938	RIA KIT, GAMMADAB ESTRIOL	Clinical Assays, Inc.	1979-01-10	51
K781850	RIA, QUANTIMUNE E3	Bio-Rad	1979-01-03	62
K781546	DIRECT ESTRIOL RIA KIT	Immunalysis Corporation	1978-12-04	82
K781599	I-ESTRIOL TEST SET	Wien Laboratories, Inc.	1978-10-17	29
K780016	HUMAN FOLLICLE STIMULATING HORMONE	Pcl-Ria, Inc.	1978-02-03	31
K772323	RIANEN ESTRIOL RIA KIT	New England Nuclear	1978-01-05	17
K772215	UNCONJUGATED ESTRIOL RIA KIT	Amersham Corp.	1977-12-22	20
K770465	RIA-120 AND ESTRIOL REAGENT SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-06-02	84

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