Hi Chem, Inc.

FDA 510(k) & PMA Approved Devices — 52 products

Total Devices52

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K960084	HICHEM GLUCOSE/HK REAGENT KIT	CFR	1996-04-04	View
510(k)	K951818	HICHEM ALT REAGENT KIT	CKA	1995-05-15	View
510(k)	K943684	HICHEM ENZYME VERIFIER KIT	JJT	1994-10-04	View
510(k)	K941764	HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808	CJY	1994-05-13	View
510(k)	K902673	HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND	JJY	1990-07-17	View
510(k)	K863617	ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)	JGS	1986-10-24	View
510(k)	K862027	LDP REAGENT CARTRIDGE (NO. 88216)	CFJ	1986-06-13	View
510(k)	K861893	GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)	JXL	1986-06-05	View
510(k)	K861879	CK REAGENT CARTRIDGE (PRODUCT NO. 88213)	CGS	1986-05-29	View
510(k)	K861419	HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE	CFJ	1986-04-28	View
510(k)	K861283	AST REAGENT CARTRIDGE	CIT	1986-04-28	View
510(k)	K861284	AP REAGENT CARTRIDGE	CJE	1986-04-28	View
510(k)	K861231	ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)	CKA	1986-04-28	View
510(k)	K855196	CLEANING REAGENT KIT PRODUCT NO 88194	JJE	1986-01-22	View
510(k)	K852867	HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE	CKA	1985-08-29	View
510(k)	K853003	HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193	JJE	1985-08-06	View
510(k)	K851350	ION 2 REAGENT KI	CEM	1985-04-29	View
510(k)	K850405	CALIBRATOR B 88133	JIX	1985-04-01	View
510(k)	K842449	HICHEM ION 2/4 SERUM RANGE CALIBRATOR	JIS	1984-08-16	View
510(k)	K842450	HICHEM ION 2/4 URINE RANGE CALIBRATOR	JIS	1984-08-16	View