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

Diatech, Inc. — Predicate Candidate Screening

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

60 daysmedian FDA review time

92 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K881685	FIBRINOGENTEST-O	Diatech, Inc.	1988-08-09	112
K854938	COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.	Diatech, Inc.	1986-03-12	92
K854090	DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT	Diatech, Inc.	1986-01-06	91
K854089	DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT	Diatech, Inc.	1986-01-06	91
K842286	DIA T1, T2 & T3	Diatech, Inc.	1984-09-11	90
K841462	HEPARIN COAGULATION CONTROL PLASMA 1-	Diatech, Inc.	1984-06-01	53
K841365	DIA REPTIN	Diatech, Inc.	1984-06-01	60
K841366	DIA FIBRIN	Diatech, Inc.	1984-06-01	60
K841523	OWREN'S VERONAL BUFFERR	Diatech, Inc.	1984-06-01	50
K841461	COAGULATION CONTROL PLASMA LEVEL 1/2/3	Diatech, Inc.	1984-05-02	23
K840802	DIA THROMBIN DIA PLASTIN	Diatech, Inc.	1984-05-01	68
K840927	FACTOR DEFICIENT SUBSTRATE PLASMA II	Diatech, Inc.	1984-04-30	59
K840928	FACTOR DEFICIENT SUBSTRATE PLASMA VIII	Diatech, Inc.	1984-04-30	59
K841522	CALCIUM CHLORIDE	Diatech, Inc.	1984-04-30	18
K840801	DIA-H 1/2/3 & DIA-HT 1/2/3	Diatech, Inc.	1984-04-25	62
K840288	DIACELIN	Diatech, Inc.	1984-04-23	90
K834571	FIBRINOGEN TEST	Diatech, Inc.	1984-02-04	37

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