Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

CDX — Predicate Candidate Screening

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

38 daysmedian FDA review time

88 days90th percentile

121clearances measured

K-number	Device	Applicant	Decided	Review days
K961490	ELECSYS T4 ASSAY	Boehringer Mannheim Corp.	1996-06-13	56
K954312	ACTIVE THYROXINE RIA	Diagnostic Systems Laboratories, Inc.	1995-10-07	22
K943416	DELFIA NEONATAL THYROXINE KIT	Wallac OY	1995-03-10	238
K934384	AXSYM(TM) TOTAL T4	Abbott Laboratories	1994-06-21	293
K932980	TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116	Sigma Diagnostics, Inc.	1993-10-18	123
K933426	STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO	Baxter Diagnostics, Inc.	1993-08-26	44
K931295	IQ TT4 ASSAY	Becton Dickinson Advanced Diagnostics	1993-07-20	127
K926563	AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT	Bio-Chem Laboratory Systems, Inc.	1993-03-18	77
K925110	ABBOTT IMX T4	Abbott Laboratories	1993-01-26	109
K925109	ABBOTT TDX/TDXFLX TT4	Abbott Laboratories	1993-01-04	87
K922945	TECHNICON DAX SYSTEM THYROXINE (T4) METHOD	Heraeus Kulzer, Inc.	1992-10-14	118
K921935	THYROXINE (T4) COATED TUBE RIA	Monobind	1992-07-07	74
K920766	T4 EIA BEAD ASSAY	Tech-Co, Inc.	1992-04-17	58
K915235	CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT	Incstar Corp.	1992-01-28	67
K912541	MILENIA TOTAL T4, CATALOG: MKT41,5	Diagnostic Products Corp.	1991-08-12	63
K911985	LUMATAG T4 CHEMILUMINESCENCE ASSAY	London Diagnostics, Inc.	1991-08-02	88
K904816	THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1991-01-17	85
K905532	CIBA CORNING ACS T4 IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1991-01-15	36
K902922	MICROZYME T4 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1990-07-27	24
K901475	CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4	Baxter Healthcare Corp	1990-06-20	85
K901939	NEOCOAT T4	Neometrics, Inc.	1990-05-31	31
K894575	TECHNICON RA SYSTEM THYROXINE T4 METHOD	Technicon Instruments Corp.	1989-10-04	75
K883559	DELFIA THYROXINE (T4) KIT	Pharmacia, Inc.	1988-12-14	117
K874623	FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101	Cyberfluor, Inc.	1988-02-16	98
K875081	IMMPULSE T4 ASSAY REAGENTS	Sclavo, Inc.	1988-02-11	64
K872286	CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1987-07-21	35
K871303	DELFIA(TM) THYROXINE (T4) KIT	Lkb Instruments, Inc.	1987-06-17	77
K871008	MICROMEDIC NEONATAL T4 KIT	Micromedic Systems	1987-05-26	74
K870965	CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1987-05-14	65
K870573	T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1987-04-22	71
K864560	IQ T4 IMMUNOASSAY	Bd Becton Dickinson Vacutainer Systems Preanalytic	1986-12-16	27
K861320	MMS T4 RIA KIT	Micromedic Systems	1986-04-24	16
K860421	STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY	American Dade	1986-02-11	7
K854798	T-4 RIASSAY	Ria Diagnostics	1986-01-15	44
K854324	PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT	Pantex, Div. Bio-Analysis, Inc.	1985-12-05	38
K840852	IMMPULSE T4 ASSAY REAGENTS	Paragon Diagnostics, Inc.	1984-04-18	54
K834023	BIO-SCIENCE LABORATORIES T4 REAGENT	Biosan Laboratories, Inc.	1984-01-24	63
K833850	T4 RIA	Syncor Intl. Corp.	1984-01-18	75
K833745	RIACOAT T-4	Immuno Assay Corp.	1984-01-04	70
K832468	T4-RIA SINGLE REAGENT	Fairlake Laboratories	1983-09-12	49
K831533	MAGIC T4 125I RADIOIMMUNOASSAY	Corning Medical & Scientific	1983-06-30	48
K831107	COAT-A-COUNT NEONATAL T4 KIT RIA KIT	Diagnostic Products Corp.	1983-05-18	43
K830642	PHASE THYROXINE RADIOIMMUNOASSAY KIT	Medical & Scientific Designs, Inc.	1983-04-05	35
K823265	MONOCLONAL ANTIBODY T4 RADIO-KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-12-09	37
K823053	NML-TETRA-TUBE RIA	Nuclear Medical Laboratories, Inc.	1982-11-10	23
K823004	BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT	Bioclinical Group	1982-11-05	24
K822399	LEECO T4 QUANT DIAGNOSTICS TEST KIT	Leeco Diagnostics, Inc.	1982-09-13	34
K821554	ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT	Amf Biological and Diagnostics Co.	1982-06-25	31
K820725	SPAC T4 RIA TEST KIT	Mallinckrodt Critical Care	1982-06-01	76
K821141	ENDAB T4 ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1982-05-13	22

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