GENCHEM, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005432203	3005432203	GENCHEM, INC.	1	N	2020-04-25	510 W Central Ave Ste D BREA CA US 92821

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00851445007006	GENCHEM™ Albumin Reagent - 10/17/2022	+1(714)529-7125	lorlow@genchem.org
00851445007013	GENCHEM™ Albumin Reagent - 10/17/2022	+1(714)529-7125	lorlow@genchem.org

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
63086	1006466317	K974833	CK-NAC REAGENT	CGS	1998-02-13
63086	1633437951	K971309	UREA	CDQ	1997-08-01
63086	1452302725	K971072	CHOLESTEROL REAGENT	CHH	1997-06-20
63086	1139857390	K970664	GLUCOSE REAGENT	CFR	1997-08-01
63086	1740598285	K965134	ALT/SGPT	CKA	1997-02-18
63086	1960153066	K965126	AST/SGOT	CIT	1997-01-17
63086	1621774698	K964914	ALKALINE PHOSPHATASE	CJE	1997-02-04
63086	1052223895	K955936	TOTAL PROTEIN REAGENT	CEK	1996-03-12
63086	1126909663	K955781	ALBUMIN	CIX	1996-03-13
63086	1133042531	K932888	INTERSECT SYSTEMS DIRECT AMYLASE REAGENT	JFJ	1994-01-31
63086	1836641924	K870827	INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT	CDT	1987-03-13
63086	1356567259	K090283	CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3	JIX	2009-06-05
63086	1662088557	K040977	GENCHEM ELECTROLYTE BUFFER	JGS	2004-12-27
63086	1519640783	K040976	GENCHEM CREATININE REAGENT	CGX	2004-12-27
63086	1732484500	K040975	GENCHEM CO2 ACID REAGENT	JFL	2004-12-27
63086	1545962645	K040974	GLUCOSE OXIDASE, GLUCOSE	CGA	2004-12-27
63086	2002197400	K040973	BUN REAGENT	CDS	2004-12-27
63086	1746107193	K040972	CALCIUM, AZO DYE REAGENT	CJY	2004-12-27
63086	1762119734	K040971	GENCHEM ISE ELECTROLYTE REFERENCE	JGS	2004-12-22
63086	1777502801	K021636	ALBUMIN REAGENT	CJW	2002-07-17
63086	1135089802	K011972	DIRECT BILIRUBIN REAGENT	CIG	2001-08-27
63086	1737834307	K003892	TOTAL BILIRUBIN REAGENT	CIG	2001-02-20
63086	1081553640
63086	1742654736
63086	1896433001
63086	1905996019
63086	2042792120

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JGS	2	2004-12-27
CIG	2	2001-08-27
JIX	1	2009-06-05
CGA	1	2004-12-27
CGX	1	2004-12-27
CDS	1	2004-12-27
JFL	1	2004-12-27
CJY	1	2004-12-27
CJW	1	2002-07-17
CGS	1	1998-02-13
CDQ	1	1997-08-01
CFR	1	1997-08-01
CHH	1	1997-06-20
CKA	1	1997-02-18
CJE	1	1997-02-04
CIT	1	1997-01-17
CIX	1	1996-03-13
CEK	1	1996-03-12
JFJ	1	1994-01-31
CDT	1	1987-03-13