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

Sigma Diagnostics, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time

145 days90th percentile

164clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021162	AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION	Sigma Diagnostics, Inc.	2002-08-30	141	0
K020109	SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL	Sigma Diagnostics, Inc.	2002-02-06	26	0
K013549	SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971	Sigma Diagnostics, Inc.	2001-12-26	63	0
K013545	SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221	Sigma Diagnostics, Inc.	2001-11-15	22	0
K013544	SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096	Sigma Diagnostics, Inc.	2001-11-15	22	0
K012410	INFINITY HBA KIT, MODELS 537-A, 537-B	Sigma Diagnostics, Inc.	2001-10-26	88	0
K010652	SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936	Sigma Diagnostics, Inc.	2001-03-30	25	0
K010158	THROMBOMAX-HS WITH CALCIUM, MODEL T6540	Sigma Diagnostics, Inc.	2001-03-22	64	0
K003267	SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A	Sigma Diagnostics, Inc.	2001-03-15	148	0
K003329	SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217	Sigma Diagnostics, Inc.	2001-03-01	128	0
K003328	ACCUCLOT CONTROL I, MODEL A4089	Sigma Diagnostics, Inc.	2001-03-01	128	0
K001403	SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17	Sigma Diagnostics, Inc.	2000-08-10	99	0
K993741	EZ LDL CHOLESTEROL TEST SYSTEM	Sigma Diagnostics, Inc.	2000-07-03	242	0
K001569	INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)	Sigma Diagnostics, Inc.	2000-06-26	38	0
K000528	ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119	Sigma Diagnostics, Inc.	2000-04-07	50	0
K000527	ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094	Sigma Diagnostics, Inc.	2000-04-07	50	0
K992712	SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334	Sigma Diagnostics, Inc.	1999-12-06	117	0
K992711	SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094	Sigma Diagnostics, Inc.	1999-12-06	117	0
K992798	SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25,	Sigma Diagnostics, Inc.	1999-09-28	40	0
K992801	SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGM	Sigma Diagnostics, Inc.	1999-09-28	40	0
K992800	SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100	Sigma Diagnostics, Inc.	1999-09-28	40	0
K992803	SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-2	Sigma Diagnostics, Inc.	1999-09-13	25	0
K984574	INFINITY GLUCOSE REAGENT	Sigma Diagnostics, Inc.	1999-02-11	50	0
K982209	ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589	Sigma Diagnostics, Inc.	1998-10-15	114	0
K982251	SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT	Sigma Diagnostics, Inc.	1998-08-18	53	0
K982236	SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT	Sigma Diagnostics, Inc.	1998-08-05	41	0
K981248	SIGMA DIAGNOSTICS ACCUCLOT CONTROL I	Sigma Diagnostics, Inc.	1998-04-29	23	0
K981255	SIGMA DIAGNOSTICS ACCUCLOT CONTROL III	Sigma Diagnostics, Inc.	1998-04-29	23	0
K981254	SIGMA DIAGNOSTICS ACCUCLOT CONTROL II	Sigma Diagnostics, Inc.	1998-04-29	23	0
K980667	INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)	Sigma Diagnostics, Inc.	1998-04-21	60	0
K980666	INFINITY AST REAGENT (PROCEDURE NO. 51)	Sigma Diagnostics, Inc.	1998-03-20	28	0
K973274	ACCUCOLOR HIGH CALIBRATOR (A3089)	Sigma Diagnostics, Inc.	1997-10-31	59	0
K972260	CS-400 COAGULATION ANALYZER SYSTEM (A1208)	Sigma Diagnostics, Inc.	1997-10-20	125	0
K972796	SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM	Sigma Diagnostics, Inc.	1997-10-10	74	1
K971858	SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)	Sigma Diagnostics, Inc.	1997-10-09	142	0
K972743	SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREA	Sigma Diagnostics, Inc.	1997-09-22	61	0
K972794	DIGOXIN DG-II FPIA REAGENT SET	Sigma Diagnostics, Inc.	1997-07-31	55	0
K972132	SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAG	Sigma Diagnostics, Inc.	1997-07-30	54	0
K972144	SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III	Sigma Diagnostics, Inc.	1997-07-25	49	0
K972041	EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR	Sigma Diagnostics, Inc.	1997-07-22	50	0
K963535	SIGMA DIAGNOSTICS GLUCOSE REAGENT	Sigma Diagnostics, Inc.	1997-01-17	135	0
K963539	SIGMA DIAGNOSTICS WASH CONCENTRATE	Sigma Diagnostics, Inc.	1996-12-16	103	0
K963543	SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2	Sigma Diagnostics, Inc.	1996-10-30	56	0
K963533	SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1	Sigma Diagnostics, Inc.	1996-10-29	55	0
K963541	SIGMA DIAGNOSTICS CO2 ACID REAGENT	Sigma Diagnostics, Inc.	1996-10-24	50	0
K963537	SIGMA DIAGNOSTICS BUN REAGENT	Sigma Diagnostics, Inc.	1996-10-24	50	0
K963538	SIGMA DIAGNOSTICS CO2ALKALINE BUFFER	Sigma Diagnostics, Inc.	1996-10-11	37	0
K963536	SIGMA DIAGNOSTICS CALICIUM REAGENT	Sigma Diagnostics, Inc.	1996-10-10	37	0
K963534	SIGMA DIAGNOSTICS CREATININE REAGENT KIT	Sigma Diagnostics, Inc.	1996-09-30	26	0
K963540	SIGMA DIAGNOSTICS ELECTROLYTE BUFFER	Sigma Diagnostics, Inc.	1996-09-27	23	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