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

American Dade — Predicate Candidate Screening

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

42 daysmedian FDA review time

77 days90th percentile

149clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K873051	STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1987-10-20	77	0
K873171	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1987-09-29	49	0
K873052	STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1987-09-14	41	0
K872789	PARAMAX URINE/CSF CALIBRATOR	American Dade	1987-09-02	50	0
K872195	DATA-FI DIMERTEST LATEX ASSAY	American Dade	1987-08-06	59	0
K872196	AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III	American Dade	1987-07-31	53	0
K871972	STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1987-07-21	61	0
K871977	DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR	American Dade	1987-07-09	48	0
K872050	PARAMAX CHOLESTEROL REAGENT	American Dade	1987-07-07	40	0
K872360	DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET	American Dade	1987-07-06	18	1
K870158	STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.	American Dade	1987-03-19	65	0
K870406	SMI DIGITRON	American Dade	1987-02-25	22	0
K870353	IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)	American Dade	1987-02-10	12	0
K870354	IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)	American Dade	1987-02-10	12	0
K864274	THROMBOPLASTIN.R	American Dade	1986-11-13	15	0
K864273	THROMBOPLASTIN.C	American Dade	1986-11-13	15	0
K864272	THROMBOPLASTIN.FS	American Dade	1986-11-13	15	0
K863887	SMI MULTIPETTOR(TM)	American Dade	1986-11-05	30	0
K863594	ACTIN FSL ACTIVATED PTT REAGENT	American Dade	1986-10-17	32	2
K863489	PARAMAX ELECTROLYTE CALIBRATOR	American Dade	1986-09-29	20	0
K862818	STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1986-08-19	26	0
K862428	STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1986-08-19	54	0
K862440	PARAMAX LIPASE REAGENT	American Dade	1986-08-04	39	0
K862067	STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1986-06-16	17	0
K860906	STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III	American Dade	1986-05-29	80	0
K860422	STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY	American Dade	1986-04-11	66	0
K860355	BOVINE CHEMISTRY CONTROL I.X AND II.X	American Dade	1986-03-17	46	0
K855199	PARAMAX COMPREHENSIVE CALIBRATOR	American Dade	1986-02-19	54	0
K860141	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.	American Dade	1986-02-11	28	0
K860421	STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY	American Dade	1986-02-11	7	0
K860140	STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.	American Dade	1986-02-06	23	0
K854651	PARAAMAX CHLORIDE DETERMINATION BY ISE	American Dade	1985-12-13	24	0
K853986	THROMBOPLASTIN-R REAGENT	American Dade	1985-11-12	46	0
K853548	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS	American Dade	1985-09-18	23	0
K853547	STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I	American Dade	1985-09-16	21	0
K853531	ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER	American Dade	1985-09-04	12	0
K853462	COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA	American Dade	1985-08-29	10	0
K853461	COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA	American Dade	1985-08-29	10	0
K852285	DADE BLOOD GAS AMPUL INJECTOR	American Dade	1985-07-09	41	0
K850574	DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO	American Dade	1985-04-12	58	0
K850575	DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H	American Dade	1985-04-10	56	0
K850570	STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1985-04-02	48	0
K844289	SERIES I/S INFECTIONS	American Dade	1984-11-19	14	0
K844158	STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1984-11-19	26	0
K842537	VON WILLEBRAND FACTOR ANTIGEN SCREEN	American Dade	1984-10-01	95	0
K842617	VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT	American Dade	1984-10-01	88	0
K843184	STRATUS LIDOCAINE FLUOROMETRIC ENZYME	American Dade	1984-09-26	44	0
K843183	STRATUS CORTISOL FLUOROMETRIC ENZYME	American Dade	1984-09-17	35	0
K843237	STRATUS QUINIDINE FLUOROMETRIC ENZYME	American Dade	1984-09-12	21	0
K842196	STRATUS PRIMIDONE FLOROMETRIC ENZY	American Dade	1984-07-11	37	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