Hichem Diagnostics

FDA Filings

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

FDA Filings

Device Company	Device	Date
PMN K981794 HICHEM DIAGNOSTICS	HICHEM CALCIUM REAGENT KIT	1998-07-29
PMN K963383 HICHEM DIAGNOSTICS	HICHEM ALP/AMP REAGENT KIT	1996-09-23
PMN K953863 HICHEM DIAGNOSTICS	HICHEM ISE STANDARDS KIT 70011	1995-09-06
PMN K953862 HICHEM DIAGNOSTICS	HICHEM ISEKCI SOLUTION KIT 70010	1995-09-06
PMN K953861 HICHEM DIAGNOSTICS	HICHEM ISE INTDERNAL REFERENCE KIT 70009	1995-09-06
PMN K953860 HICHEM DIAGNOSTICS	HICHEM ISE DILUENT KIT 70008	1995-09-06
PMN K951751 HICHEM DIAGNOSTICS	HICHEM AST REAGENT KIT	1995-08-02
PMN K946192 HICHEM DIAGNOSTICS	HICHEM Y-GT REAGENT KIT	1995-05-02
PMN K946022 HICHEM DIAGNOSTICS	HICHEM LDH/L REAGENT KIT	1995-02-23
PMN K941433 HICHEM DIAGNOSTICS	HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH	1994-08-02
PMN K925612 HICHEM DIAGNOSTICS	HI CHEM ELECTROLYTE BUFFER	1993-04-20
PMN K925551 HICHEM DIAGNOSTICS	HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807	1993-04-20
PMN K925550 HICHEM DIAGNOSTICS	HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806	1993-04-20
PMN K925611 HICHEM DIAGNOSTICS	HI CHEM ELECTROLYTE REFERENCE REAGENT	1993-02-23
PMN K925553 HICHEM DIAGNOSTICS	HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813	1993-02-12
PMN K925552 HICHEM DIAGNOSTICS	HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812	1993-02-12
PMN K913792 HICHEM DIAGNOSTICS	HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL	1991-09-25
PMN K911803 HICHEM DIAGNOSTICS	HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED	1991-05-15
PMN K904099 HICHEM DIAGNOSTICS	URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS	1990-10-26
PMN K904293 HICHEM DIAGNOSTICS	HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)	1990-10-12
PMN K903888 HICHEM DIAGNOSTICS	HI CHEM PROTEIN/LIPIDS LINEARITY	1990-09-27
PMN K902321 HICHEM DIAGNOSTICS	HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)	1990-06-28
PMN K902155 HICHEM DIAGNOSTICS	HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)	1990-06-12
PMN K901115 HICHEM DIAGNOSTICS	MULTICONSTITUENT SERUM RANGE LINEARITY #88234	1990-04-19
PMN K895555 HICHEM DIAGNOSTICS	MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)	1989-12-22
PMN K895585 HICHEM DIAGNOSTICS	HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)	1989-11-13
PMN K895135 HICHEM DIAGNOSTICS	HI CHEM CALIBRATOR A+	1989-10-23
PMN K890671 HICHEM DIAGNOSTICS	HI CHEM CREATININE REAGENT (PRODUCT #88809)	1989-05-09
PMN K890773 HICHEM DIAGNOSTICS	HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196	1989-04-18
PMN K890990 HICHEM DIAGNOSTICS	EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE	1989-04-10
PMN K890584 HICHEM DIAGNOSTICS	HI CHEM CALCIUM REAGENT #88808	1989-04-10
PMN K890583 HICHEM DIAGNOSTICS	HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2	1989-03-13
PMN K890578 HICHEM DIAGNOSTICS	HI CHEM WASH CONCENTRATE REAGENT #88805	1989-03-10
PMN K890184 HICHEM DIAGNOSTICS	MODIFIED INTENDED USE OF CLEANING REAGENT KIT	1989-02-07
PMN K890183 HICHEM DIAGNOSTICS	MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.	1989-02-07
PMN K883844 HICHEM DIAGNOSTICS	HI CHEM KINETIC CHOLESTEROL REAGENT #88218	1988-10-31
PMN K883405 HICHEM DIAGNOSTICS	TRIGLYCERIDES REAGENT (PRODUCT #88218)	1988-09-13
PMN K883404 HICHEM DIAGNOSTICS	URIC ACID REAGENT (PRODUCT #88219)	1988-09-13
PMN K881438 HICHEM DIAGNOSTICS	UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN	1988-07-06
PMN K881437 HICHEM DIAGNOSTICS	CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS	1988-07-06
PMN K881436 HICHEM DIAGNOSTICS	SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS	1988-06-02