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

CFL — Predicate Candidate Screening

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

42 daysmedian FDA review time

192 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972761	SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY	Sealite Sciences, Inc.	1997-09-25	63	0
K971353	DSL ACTIVE NON-EXTRACTION IGF-I ELISA	Diagnostic Systems Laboratories, Inc.	1997-05-12	31	0
K970701	DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)	Diagnostic Systems Laboratories, Inc.	1997-04-02	35	0
K962758	DSL 9100 IGF-II IRMA	Diagnostic Systems Laboratories, Inc.	1996-08-30	45	0
K961678	HUMAN GROWTH HORMONE IMMUNOASSAY KIT	Nichols Institute Diagnostics	1996-07-08	68	0
K961172	DSL ACTIVE NON-EXTRACTION IGF-I IRMA	Diagnostic Systems Laboratories, Inc.	1996-04-23	29	0
K960551	DSL ACTIVE HUMAN GROWTH HORMONE ELISA	Diagnostic Systems Laboratories, Inc.	1996-03-06	27	0
K955376	IMMULITE HGH	Diagnostic Products Corp.	1996-02-16	84	0
K955390	INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY	Corning Nichols Diagnostics	1995-12-29	35	0
K952505	INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASS	Nichols Institute	1995-07-03	33	0
K946247	IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3	Nichols Institute	1995-06-23	183	0
K951752	ACTIVE IGF-I ELISA	Diagnostic Systems Laboratories, Inc.	1995-05-10	23	0
K951707	DSL ACTIVE IFGBP-3 ELISA	Diagnostic Systems Laboratories, Inc.	1995-05-10	27	1
K950510	OCTEIA IGF-1 KIT	Immunodiagnostic Systems , Ltd.	1995-04-05	58	0
K950228	DSL ACTIVE IGFBP-3 IRMA (DSL 6600)	Diagnostic Systems Laboratories, Inc.	1995-02-22	42	1
K930047	DSL IGFBP-3 RIA (DSL 6700)	Diagnostic Systems Laboratories, Inc.	1994-07-06	547	0
K921868	ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT	Endocrine Sciences Products	1994-01-03	623	0
K930484	DELFIA(R) HGH KIT	Wallac OY	1993-05-11	102	0
K920299	MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT	Medix Biotech, Inc.	1992-03-04	42	0
K912858	LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY	London Diagnostics, Inc.	1991-07-30	32	0
K905757	AIA-PACK HGH	Tosoh Medics, Inc.	1991-01-25	29	0
K905098	ELEGANCE GH ELISA	Bioclone Australia Pty , Ltd.	1990-12-06	23	0
K896808	IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I	Nichols Institute Diagnostics	1990-01-19	46	0
K896643	HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015	Medix Biotech, Inc.	1989-12-29	35	0
K882823	FIAGEN HGH FLUOROIMMUNOASSAY KIT	Cyberfluor, Inc.	1988-08-30	53	0
K875229	DSL SOMATOMEDIN-C (DSL #5600)	Diagnostic Systems Laboratories, Inc.	1988-07-01	192	0
K860228	SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA	Boots-Celltech Diagnostics, Inc.	1986-02-28	37	0
K852299	TERUMO SENSIBEAD EIA HGH KIT	Terumo Medical Corp.	1985-07-09	41	0
K850892	SOMATOMEDIN C BY RADIOIMMUNOASSAY	Immuno Nuclear Corp.	1985-06-06	94	0
K851259	HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT	Nichols Institute Diagnostics	1985-05-13	46	0
K841088	SOMATOMEDIN-C RADIOIMMUNOASSAY KIT	Nichols Institute Diagnostics	1984-10-22	223	0
K841094	HUMAN GROWTH HORMONE RIA KIT	Diagnostic Products Corp.	1984-05-07	55	0
K831073	DAC-CEL HCG-MCA KIT RD52	Wellcome Diagnostics	1983-09-01	150	0
K821366	TANDEM - HGH KIT	Hybritech, Inc.	1982-06-10	31	0
K803280	HUMAN GROWTH HORMONE-RADIOIMM. KIT	Immuno Nuclear Corp.	1981-01-16	18	0
K780347	RIA SYS. FOR HUMAN GROWTH HORMONE	Calbiochem-Behring Corp.	1978-04-12	41	0

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