Hi Chem Inc

FDA Filings

This page includes the latest FDA filings for Hi Chem Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K960084 HI CHEM, INC.	HICHEM GLUCOSE/HK REAGENT KIT	1996-04-04
PMN K951818 HI CHEM, INC.	HICHEM ALT REAGENT KIT	1995-05-15
PMN K943684 HI CHEM, INC.	HICHEM ENZYME VERIFIER KIT	1994-10-04
PMN K941764 HI CHEM, INC.	HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808	1994-05-13
PMN K902673 HI CHEM, INC.	HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND	1990-07-17
PMN K863617 HI CHEM, INC.	ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)	1986-10-24
PMN K862027 HI CHEM, INC.	LDP REAGENT CARTRIDGE (NO. 88216)	1986-06-13
PMN K861893 HI CHEM, INC.	GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)	1986-06-05
PMN K861879 HI CHEM, INC.	CK REAGENT CARTRIDGE (PRODUCT NO. 88213)	1986-05-29
PMN K861419 HI CHEM, INC.	HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE	1986-04-28
PMN K861284 HI CHEM, INC.	AP REAGENT CARTRIDGE	1986-04-28
PMN K861283 HI CHEM, INC.	AST REAGENT CARTRIDGE	1986-04-28
PMN K861231 HI CHEM, INC.	ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)	1986-04-28
PMN K855196 HI CHEM, INC.	CLEANING REAGENT KIT PRODUCT NO 88194	1986-01-22
PMN K852867 HI CHEM, INC.	HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE	1985-08-29
PMN K853003 HI CHEM, INC.	HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193	1985-08-06
PMN K851350 HI CHEM, INC.	ION 2 REAGENT KI	1985-04-29
PMN K850405 HI CHEM, INC.	CALIBRATOR B 88133	1985-04-01
PMN K842450 HI CHEM, INC.	HICHEM ION 2/4 URINE RANGE CALIBRATOR	1984-08-16
PMN K842449 HI CHEM, INC.	HICHEM ION 2/4 SERUM RANGE CALIBRATOR	1984-08-16
PMN K842025 HI CHEM, INC.	ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL	1984-06-22
PMN K841572 HI CHEM, INC.	DIRECT BILIRUBIN REAGENT	1984-05-16
PMN K833159 HI CHEM, INC.	POTASSIUM ELECTRODE TIP ASSAMBLY-K-	1983-11-25
PMN K831295 HI CHEM, INC.	AMYLASE REAGENT #88129	1983-06-30
PMN K830714 HI CHEM, INC.	TOTAL BILIRUBIN REAGENT	1983-04-06
PMN K830137 HI CHEM, INC.	CALIBRATOR A	1983-02-07
PMN K821225 HI CHEM, INC.	ALBUMIN REAGENT	1982-05-21
PMN K820090 HI CHEM, INC.	ASTRA-T CALCIUM REAGENT	1982-01-28
PMN K813536 HI CHEM, INC.	ASTRA TOTAL PROTEIN REAGENT	1981-12-31
PMN K813370 HI CHEM, INC.	ELECTROLYTE GEL	1981-12-22
PMN K812700 HI CHEM, INC.	URICAR	1981-11-05
PMN K802264 HI CHEM, INC.	WASH SOLUTION KIT, #88102	1980-10-31
PMN K802392 HI CHEM, INC.	ASTRA PRINTER PAPER #88112-CHLORIDE SILV	1980-10-23
PMN K801892 HI CHEM, INC.	KLINAR REAGENT PAK, #36010	1980-10-23
PMN K800616 HI CHEM, INC.	BUN REAGENT KIT #88108	1980-04-10
PMN K791365 HI CHEM, INC.	FAST FLOW #60310	1979-09-27
PMN K791696 HI CHEM, INC.	CONTRO II	1979-09-24
PMN K791695 HI CHEM, INC.	CONTRO I	1979-09-24
PMN K791694 HI CHEM, INC.	CALIBRATOR II	1979-09-17
PMN K791693 HI CHEM, INC.	CALIBRATOR I	1979-09-17
PMN K791692 HI CHEM, INC.	SODIUM/POTASSIUM BUFFER SOLUTION	1979-09-17
PMN K791691 HI CHEM, INC.	SODIUM/POTASSIUM CONDITIONING SOLUTION	1979-09-17
PMN K791690 HI CHEM, INC.	CHOLORDE REAGENT	1979-09-17
PMN K791689 HI CHEM, INC.	PICRIC SOLUTION	1979-09-17
PMN K791688 HI CHEM, INC.	ALKALINE BUFFER	1979-09-17
PMN K791687 HI CHEM, INC.	CO2 REFERENCE REAGENT	1979-09-17
PMN K791686 HI CHEM, INC.	CO2 CUP REAGENT	1979-09-17
PMN K791685 HI CHEM, INC.	GLUCOSE REAGENT	1979-09-17
PMN K782094 HI CHEM, INC.	HILAR	1979-01-17
PMN K781132 HI CHEM, INC.	CHEMLAR	1978-08-10
PMN K771731 HI CHEM, INC.	CHOLAR PRODU&T #17010	1977-10-25
PMN K771000 HI CHEM, INC.	TRENDAR	1977-07-15

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