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

New England Nuclear — Predicate Candidate Screening

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

34 daysmedian FDA review time

83 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K841478	RIANEN CYCLIC-AMP RADIOIMMUNOASSAY	New England Nuclear	1984-06-14	66
K840301	RIANEN ESTRIOL RADIOIMMUNOASSAY KIT	New England Nuclear	1984-03-30	66
K834038	RIANEN FOLLICLE STIMULATING HORMONE	New England Nuclear	1984-01-30	68
K833376	RIANEN LUTEINIZING HORMONE RIA KIT	New England Nuclear	1983-12-20	83
K831345	RIANEN PROLACTIN 125I KIT	New England Nuclear	1983-06-08	44
K801245	ATOMLIGHT (LIQUID SCINTILLATION SOLUTION	New England Nuclear	1980-06-20	24
K792175	RIANEN, VITAMIN B12 ASSAY SYSTEM	New England Nuclear	1979-11-13	15
K790817	RIA KIT, QUANTITATION OF PROSTATIC ACID	New England Nuclear	1979-05-07	10
K782110	RIA KIT, RIANEN CORTISOL	New England Nuclear	1979-01-26	38
K781888	ASSAY SYSTEM, FERRITIN I KIT	New England Nuclear	1979-01-10	64
K781495	RIANEN ASSAY SYSTEM, 125I KIT	New England Nuclear	1978-09-14	15
K780182	TOBRAMYCIN 125I RIA KIT	New England Nuclear	1978-02-13	10
K772425	RIANEN GENTAMICIN RIA KIT	New England Nuclear	1978-01-05	7
K772323	RIANEN ESTRIOL RIA KIT	New England Nuclear	1978-01-05	17
K771590	THYROID STIMULATING HORMONE	New England Nuclear	1977-09-15	27
K761346	RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)	New England Nuclear	1977-01-07	10
K760619	RADIO IMMUNO ASSAY KIT/	New England Nuclear	1976-12-06	84
K760068	KIT, RIA, GENTAMICIN SULF.	New England Nuclear	1976-07-20	34

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