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

Nichols Institute Diagnostics — Predicate Candidate Screening

68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time

270 days90th percentile

68clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050784	NICHOLS ADVANTAGE ALDOSTERONE ASSAY	Nichols Institute Diagnostics	2005-06-01	65	0
K042676	NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTR	Nichols Institute Diagnostics	2004-12-17	79	1
K042689	NICHOLS ADVANTAGE CORTISOL	Nichols Institute Diagnostics	2004-12-09	71	0
K040813	NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMO	Nichols Institute Diagnostics	2004-06-08	70	0
K033727	NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY	Nichols Institute Diagnostics	2004-04-22	146	1
K033302	NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040	Nichols Institute Diagnostics	2004-01-26	104	0
K032188	NICHOLS ADVANTAGE ALDOSTERONE ASSAY	Nichols Institute Diagnostics	2003-07-31	14	0
K022356	NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG	Nichols Institute Diagnostics	2002-10-25	98	0
K022472	PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTR	Nichols Institute Diagnostics	2002-10-09	75	0
K013992	NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID H	Nichols Institute Diagnostics	2001-12-13	9	0
K012367	VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D	Nichols Institute Diagnostics	2001-10-09	75	1
K011128	NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VER	Nichols Institute Diagnostics	2001-09-06	146	0
K002888	NICHOLS ADVANTAGE THYROGLOB	Nichols Institute Diagnostics	2000-10-20	35	0
K994140	NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240	Nichols Institute Diagnostics	2000-05-09	153	0
K992188	NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECE	Nichols Institute Diagnostics	1999-12-06	160	0
K980737	ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY	Nichols Institute Diagnostics	1999-03-23	391	0
K984520	NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MO	Nichols Institute Diagnostics	1999-02-05	46	0
K984186	NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY	Nichols Institute Diagnostics	1999-02-02	71	0
K983992	NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY	Nichols Institute Diagnostics	1999-01-26	78	0
K982866	NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOA	Nichols Institute Diagnostics	1998-10-16	63	0
K980716	ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA)	Nichols Institute Diagnostics	1998-04-03	86	0
K972070	NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONT	Nichols Institute Diagnostics	1997-06-26	23	0
K964635	NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT	Nichols Institute Diagnostics	1997-05-21	183	0
K962208	NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT	Nichols Institute Diagnostics	1997-04-08	302	0
K962687	GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM	Nichols Institute Diagnostics	1997-03-28	260	0
K962408	NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT	Nichols Institute Diagnostics	1997-03-18	270	0
K965058	NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT	Nichols Institute Diagnostics	1997-03-11	83	0
K961142	STRATEC LIA II ANALYZER	Nichols Institute Diagnostics	1997-02-18	334	0
K962601	NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORM	Nichols Institute Diagnostics	1996-12-24	175	1
K962598	NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMO	Nichols Institute Diagnostics	1996-12-10	161	0
K962033	CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT	Nichols Institute Diagnostics	1996-09-27	126	0
K961650	NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORM	Nichols Institute Diagnostics	1996-07-16	77	0
K961678	HUMAN GROWTH HORMONE IMMUNOASSAY KIT	Nichols Institute Diagnostics	1996-07-08	68	0
K945961	CALCITONIN IMMUNOASSAY KIT	Nichols Institute Diagnostics	1995-11-20	348	0
K954418	INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)	Nichols Institute Diagnostics	1995-11-03	42	0
K950029	5STRATEC SL 300 LIA-MAT	Nichols Institute Diagnostics	1995-08-02	210	0
K950921	CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY	Nichols Institute Diagnostics	1995-05-02	62	0
K935319	CHEMILUMINESCENCE LH	Nichols Institute Diagnostics	1995-04-05	532	0
K926220	T3 UPTAKE CHEMILUMINESCENCE ASSAY	Nichols Institute Diagnostics	1993-11-17	342	0
K925998	ACTIVE RENIN IMMUNORADIOMETRIC ASSAY	Nichols Institute Diagnostics	1993-01-06	40	0
K925702	NICHOLS APO B CHEMILUMINESCENCE ASSAY	Nichols Institute Diagnostics	1992-12-23	41	0
K923015	TOTAL T3 CHEMILUMINESCENCE ASSAY	Nichols Institute Diagnostics	1992-09-02	72	0
K896808	IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I	Nichols Institute Diagnostics	1990-01-19	46	0
K896222	FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT	Nichols Institute Diagnostics	1989-11-17	18	0
K882741	ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES	Nichols Institute Diagnostics	1988-08-30	60	0
K881123	ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.	Nichols Institute Diagnostics	1988-04-28	43	0
K881124	ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY	Nichols Institute Diagnostics	1988-04-18	33	0
K874572	ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM	Nichols Institute Diagnostics	1987-12-02	27	0
K872390	ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM	Nichols Institute Diagnostics	1987-09-02	75	0
K863678	FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM	Nichols Institute Diagnostics	1986-10-16	27	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