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

KHQ — Predicate Candidate Screening

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

41 daysmedian FDA review time

104 days90th percentile

93clearances measured

K-number	Device	Applicant	Decided	Review days
K981375	ACE T UPTAKE REAGENT TU CALIBRATORS	Schiapparelli Biosystems, Inc.	1998-06-10	55
K980088	T-UPTAKE MICROPLATE EIA	Monobind	1998-02-04	26
K970539	CHIRON DIAGNOSTICS ACS:180TU P	Chiron Diagnostics Corp.	1997-03-24	40
K964308	VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GE	Johnson & Johnson Clinical Diagnostics, Inc.	1996-11-27	29
K961488	ELECSYS T-UPTAKE ASSAY	Boehringer Mannheim Corp.	1996-06-12	55
K954807	CEDIA T UPTAKE ASSAY	Boehringer Mannheim Corp.	1995-12-21	63
K951586	T-UPTAKE EIA TEST	Diagnostic Reagents, Inc.	1995-05-15	39
K933414	STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1994-11-22	497
K934312	AXSYM(TM) T-UPTAKE	Abbott Laboratories	1994-06-21	293
K935816	VIDAS T UPTAKE	Biomerieux Vitek, Inc.	1994-03-22	110
K926220	T3 UPTAKE CHEMILUMINESCENCE ASSAY	Nichols Institute Diagnostics	1993-11-17	342
K931294	IQ TUPTAKE ASSAY	Becton Dickinson Advanced Diagnostics	1993-07-22	129
K926443	COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS	Roche Diagnostic Systems, Inc.	1993-05-20	148
K925257	CIBA CORNING ACS T UPTAKE IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1992-12-28	70
K923676	VISTA THYROXINE UPTAKE ASSAY	Syva Co.	1992-10-09	79
K913663	AIA-PACK T-U	Tosoh Corp.	1991-09-30	45
K911912	SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)	Serono-Baker Diagnostics, Inc.	1991-09-18	141
K911093	CIBA CORNING ACS T UPTAKE IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1991-04-29	48
K903396	IL T UPTAKE ASSAY SYSTEM	Instrumentation Laboratory CO	1990-10-12	77
K902748	SEROZYME FREE T3 IMMUNOASSAY	Advanced Magnetics, Inc.	1990-08-09	48
K902797	OPUS TM T-UPTAKE TEST SYSTEM	Pb Diagnostic Systems, Inc.	1990-07-30	34
K896925	T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT	In Vitro Diagnostics, Inc.	1990-01-18	37
K895186	FIAGEN T3 UPTAKE CATALOGUE #101-402	Cyberfluor, Inc.	1989-11-08	89
K894145	EMIT T-UPTAKE ASSAY	Syva Co.	1989-09-05	83
K892224	D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN	Photec Diagnostics, Inc.	1989-06-16	74
K891068	VENTREX COATED TUBE T3 UPTAKE	Ventrex Laboratories, Inc.	1989-04-10	40
K885259	ACA THYRONINE UPTAKE (TU E) METHOD	The DU Pont Co.	1989-02-17	56
K883765	TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE	Biotecx Laboratories, Inc.	1988-10-31	55
K883085	T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS	Serono Diagnostics, Inc.	1988-09-09	49
K881855	EMIT CONVENIENCE PACK: T-UPTAKE ASSAY	Syva Co.	1988-06-10	38
K880619	EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO	Syva Co.	1988-04-18	62
K874362	AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144	Amersham Corp.	1988-02-18	118
K872447	CEDIA(TM) T UPTAKE	Microgenics Corp.	1987-08-21	59
K872172	IMMUBEAD THYROID UPTAKE	Immunotech Corp.	1987-08-17	70
K865083	AFFINITY(TM) I UPTAKE IMMUNIT(TM)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-07-09	191
K864132	CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1986-12-16	56
K862447	PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT	Pantex, Div. Bio-Analysis, Inc.	1986-10-07	102
K862968	FREE T3 RADIOIMMUNOASSAY KIT	Bioclinical Group	1986-09-25	50
K861262	MMS T3 UPTAKE	Micromedic Systems	1986-05-23	49
K860422	STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY	American Dade	1986-04-11	66
K855169	T3 UPTAKE RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1986-02-06	42
K855033	T-3 UPTAKE/RIASSAY	Ria Diagnostics	1986-01-24	38
K842694	TERUMO SENSIBEAD EIA THYROID UPTAKE KIT	Terumo Medical Corp.	1984-09-07	58
K841927	T3 UPTAKE	Syncor Intl. Corp.	1984-06-25	46
K840853	IMMPULSE TBC ASSAY REAGENTS	Paragon Diagnostics, Inc.	1984-04-01	37
K840589	TRI-TUBE RIA	Nuclear Medical Laboratories, Inc.	1984-03-09	29
K834209	STRATUS THYROID UPTAKE FLUOROMETRIC	American Dade	1984-03-09	95
K833703	ACA THYROXINE UPTAKE ANALYTICAL TEST	E.I. Dupont DE Nemours & Co., Inc.	1984-01-30	104
K831613	MAGIC TM 125I T3 UPTAKE RADIOASSAY	Corning Medical & Scientific	1983-08-11	84
K830900	UPTAKE T3 RADIOIMMUNOASSAY KIT	Medical & Scientific Designs, Inc.	1983-04-18	28

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