Medical device manufacturer

Sigma Chemical Co.

Sigma Chemical Co. holds 231 FDA 510(k) clearances across 92 product codes. Median elapsed review time is 41 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 231
Product codes: 92
Median review: 41 days
Recall records: 0

How does FDA spell Sigma Chemical Co.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Sigma Chemical Co. file in?

92 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
KIT	Media And Components, Synthetic Cell And Tissue Culture	87	38 days	22 November 1988
GGP	Test, Qualitative And Quantitative Factor Deficiency	9	71 days	29 May 1986
GJT	Plasma, Coagulation Factor Deficient	8	36 days	6 March 1990
CHH	Enzymatic Esterase--Oxidase, Cholesterol	4	36 days	9 August 1990
GKZ	Counter, Differential Cell	4	597 days	31 October 1991
JFL	Ph Rate Measurement, Carbon-Dioxide	4	133 days	3 January 1994
KIP	Formulations, Balanced Salt Solutions	4	55 days	30 March 1987
GGN	Plasma, Coagulation Control	3	58 days	26 July 1990
GHD	Test, Leukocyte Alkaline Phosphatase	3	106 days	18 December 1990
HYB	Eosin Y	3	14 days	31 March 1988
JIX	Calibrator, Multi-Analyte Mixture	3	71 days	13 October 1993
CFR	Hexokinase, Glucose	2	36 days	22 May 1984
CGA	Glucose Oxidase, Glucose	2	34 days	4 November 1994
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	2	28 days	25 June 1984
CGX	Alkaline Picrate, Colorimetry, Creatinine	2	8 days	18 October 1993
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	2	15 days	3 August 1977
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	2	54 days	20 June 1989
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	2	41 days	20 July 1989
DEL	Lipoprotein X, Antigen, Antiserum, Control	2	16 days	26 April 1990
GFO	Activated Partial Thromboplastin	2	14 days	8 November 1990
GIA	Test, Leukocyte Peroxidase	2	30 days	4 January 1985
GJS	Test, Time, Prothrombin	2	34 days	3 July 1990
HYJ	Hematoxylin	2	14 days	2 June 1982
JGJ	Photometric Method, Magnesium	2	42 days	10 November 1988
JJW	Urinalysis Controls (Assayed And Unassayed)	2	15 days	12 September 1984

Showing the 25 they file in most, of 92.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Sigma Chemical Co. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Sigma Chemical Co. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K933694	SIGMA GLUCOSE REAGENT	CGA	4 November 1994	463
K933678	SIGMA CALCIUM REAGENT	CJY	11 March 1994	225
K933696	SIGMA ELECTROLYTE REFERENCE REAGENT	JFL	3 January 1994	158
K933691	SIGMA CO2 ALKALINE BUFFER REAGENT	JFL	17 December 1993	141
K933679	SIGMA BUN REAGENT	LFP	17 December 1993	142
K933703	SIGMA WASH CONCENTRATE SOLUTION	JJE	10 December 1993	134
K933692	SIGMA CO2 ACID REAGENT	JFL	9 December 1993	133
K933695	SIGMA ELECTROLYTE BUFFER	JFL	22 October 1993	85
K933697	SIGMA CRE REAGENT	CGX	18 October 1993	81
K933693	SIGMA CX-3 CALIBRATION STANDARD LEVEL 2	JIX	13 October 1993	76

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.