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

CEE — Predicate Candidate Screening

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

43 daysmedian FDA review time

96 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K952284	AMERLITE TBG ASSAY	Johnson & Johnson Clinical Diagnostics, Inc.	1995-07-26	71
K930010	ACCESS THYROID UPTAKE ASSAY	Bio-Rad Laboratories, Inc.	1993-06-07	154
K910677	IMMULITE(TM) T-UPTAKE	Cirrus Diagnostics, Inc.	1991-04-29	73
K905777	MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT	Immunotech Corp.	1991-01-30	34
K900240	DELFIA TBG KIT	Pharmacia, Inc.	1990-03-30	72
K896991	ENZYMUN TEST(R) TBK	Boehringer Mannheim Corp.	1990-03-01	78
K893469	AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT	Amersham Corp.	1989-08-15	103
K885034	T-UPTAKE MICROASSAY	Diamedix Corp.	1989-02-02	59
K884201	FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT	Cyberfluor, Inc.	1988-12-14	69
K874658	TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)	Technicon Instruments Corp.	1987-12-18	36
K862109	ENZYMUN TEST TBG	Boehringer Mannheim Corp.	1986-06-30	27
K861735	TIPSEP-TBG ASSAY	Nuclear Diagnostics, Inc.	1986-06-13	38
K842167	TBG RIA	Syncor Intl. Corp.	1984-07-09	39
K842010	THYROXINE-BINDING GLOBULIN RADIOUMMU	Nichols Institute Diagnostics	1984-06-25	39
K841024	VENTREZYME T4U IMMUNOASSAY T4U	Ventrex Laboratories, Inc.	1984-05-09	58
K822684	ENDAB THYROID UPTAKE	Immunotech Corp.	1982-10-08	35
K820252	TBG DIAGNOSTIC KIT	Diagnostic Reagents, Inc.	1982-05-05	96
K810967	IN-VITRO TBG RADIOIMMUNOASSAY TEST	Clinical Assays, Inc.	1981-04-23	15
K800204	RIA PHASE TBG	Boehringer Mannheim Corp.	1980-03-19	49
K781225	GLOBULIN TEST, HUMAN THYROXINE BINDING	Hyland Therapeutic Div., Travenol Laboratories	1978-08-31	44
K780671	125 I-T3 UPTAKE REAGENT	Radioimmunoassay, Inc.	1978-06-06	43
K780486	STIKSEP-T3 KIT	Nuclear Diagnostics, Inc.	1978-04-28	32
K772183	THYROID BINDING GLOBULIN	Corning Medical & Scientific	1977-12-20	25
K771341	SPINSEP-TBG	Nuclear Diagnostics, Inc.	1977-08-10	22
K760134	PROCEDURE, RA, THYROXINE BINDING PROTEIN	Bio-Rad	1976-07-20	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