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

DKC — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

47 daysmedian FDA review time

109 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K031392	MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL	Medical Analysis Systems, Inc.	2003-07-01	60
K935819	QUALITY CONTROL MATERIAL (ASSAYED)	Columbia Diagnostics, Inc.	1994-03-22	109
K933425	AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812	Sigma Diagnostics, Inc.	1993-11-16	126
K934467	BECKMAN CX AMMONIA/ALCOHOL CONTROL	Beckman-Diagnostic Systems Group	1993-10-27	47
K932067	ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III	Sigma Diagnostics, Inc.	1993-06-16	48
K912827	SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3	Cala Diagnostics	1991-08-12	47
K912826	WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2	Cala Diagnostics	1991-07-26	30
K843872	ETHANOL CONTROLS LOW & HIGH E5133/E5258	Sigma Chemical Co.	1984-10-31	29
K833514	TOXI CHEM SERUM ALCOHOL CONTROL	Fisher Diagnostics	1983-12-08	58
K810465	EMIT-ST ETHYL ALCOHOL SERUM CONTROLS	Syva Co.	1981-03-06	11
K802618	EMIT-STM ETHYL ALCOHOL URINE CONTROLS	Syva Co.	1980-10-31	11

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