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

Princeton Biomedix · Predicate Candidate Screening

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

84 daysmedian FDA review time

285 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K942052	LIFESIGN MI MYOGLOBIN	Princeton Biomedix	1995-02-07	285
K925355	BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST	Princeton Biomedix	1994-07-12	628
K930185	OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP	Princeton Biomedix	1993-03-04	49
K925183	BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST	Princeton Biomedix	1993-02-23	132
K926308	LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST	Princeton Biomedix	1993-01-26	42
K901011	BIOSIGN HCG-ONE STEP PREGNANCY TEST	Princeton Biomedix	1990-05-04	60
K894705	BIOSPOT HCG-RAPID PREGNANCY TEST	Princeton Biomedix	1989-10-18	85
K894750	BIOSTIX I. HCG - ONE STEP PREGNANCY TEST	Princeton Biomedix	1989-10-18	84
K892654	BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST	Princeton Biomedix	1989-06-19	67
K761315	ALKALINE PHOSPHATASE (ALP)/PNPP	Princeton Biomedix	1977-02-24	63
K760346	ASSAY FOR GAMMA GLUTAMYLTRANSFERASE	Princeton Biomedix	1976-10-27	86
K760345	TEST, LACTATE DEHYDROGENASE	Princeton Biomedix	1976-10-27	86
K760347	SET, TRINDER GLUCOSE	Princeton Biomedix	1976-10-05	64
K760161	TEST, ACID PHOSPHATASE	Princeton Biomedix	1976-07-20	18

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