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FDA 510(k) Applications Submitted by HICHEM DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K890578 02/06/1989 HI CHEM WASH CONCENTRATE REAGENT #88805 HICHEM DIAGNOSTICS
K890583 02/06/1989 HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 HICHEM DIAGNOSTICS
K890584 02/06/1989 HI CHEM CALCIUM REAGENT #88808 HICHEM DIAGNOSTICS
K890671 02/09/1989 HI CHEM CREATININE REAGENT (PRODUCT #88809) HICHEM DIAGNOSTICS
K901115 03/09/1990 MULTICONSTITUENT SERUM RANGE LINEARITY #88234 HICHEM DIAGNOSTICS
K911803 04/23/1991 HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED HICHEM DIAGNOSTICS
K902155 05/15/1990 HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) HICHEM DIAGNOSTICS
K883404 08/11/1988 URIC ACID REAGENT (PRODUCT #88219) HICHEM DIAGNOSTICS
K883405 08/11/1988 TRIGLYCERIDES REAGENT (PRODUCT #88218) HICHEM DIAGNOSTICS
K913792 08/23/1991 HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL HICHEM DIAGNOSTICS
K895555 09/06/1989 MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) HICHEM DIAGNOSTICS
K904099 09/06/1990 URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS HICHEM DIAGNOSTICS
K890773 02/15/1989 HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 HICHEM DIAGNOSTICS
K902321 05/23/1990 HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) HICHEM DIAGNOSTICS
K904293 09/19/1990 HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) HICHEM DIAGNOSTICS
K890183 01/18/1989 MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. HICHEM DIAGNOSTICS
K890184 01/18/1989 MODIFIED INTENDED USE OF CLEANING REAGENT KIT HICHEM DIAGNOSTICS
K890990 02/27/1989 EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE HICHEM DIAGNOSTICS
K941433 03/24/1994 HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH HICHEM DIAGNOSTICS
K881436 04/05/1988 SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS HICHEM DIAGNOSTICS
K881437 04/05/1988 CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS HICHEM DIAGNOSTICS
K881438 04/05/1988 UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN HICHEM DIAGNOSTICS
K951751 04/17/1995 HICHEM AST REAGENT KIT HICHEM DIAGNOSTICS
K981794 05/21/1998 HICHEM CALCIUM REAGENT KIT HICHEM DIAGNOSTICS
K895135 08/16/1989 HI CHEM CALIBRATOR A+ HICHEM DIAGNOSTICS
K953860 08/17/1995 HICHEM ISE DILUENT KIT 70008 HICHEM DIAGNOSTICS
K953861 08/17/1995 HICHEM ISE INTDERNAL REFERENCE KIT 70009 HICHEM DIAGNOSTICS
K953862 08/17/1995 HICHEM ISEKCI SOLUTION KIT 70010 HICHEM DIAGNOSTICS
K953863 08/17/1995 HICHEM ISE STANDARDS KIT 70011 HICHEM DIAGNOSTICS
K903888 08/22/1990 HI CHEM PROTEIN/LIPIDS LINEARITY HICHEM DIAGNOSTICS
K963383 08/27/1996 HICHEM ALP/AMP REAGENT KIT HICHEM DIAGNOSTICS
K883844 09/12/1988 HI CHEM KINETIC CHOLESTEROL REAGENT #88218 HICHEM DIAGNOSTICS
K895585 09/15/1989 HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) HICHEM DIAGNOSTICS
K925550 11/03/1992 HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 HICHEM DIAGNOSTICS
K925551 11/03/1992 HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 HICHEM DIAGNOSTICS
K925552 11/03/1992 HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 HICHEM DIAGNOSTICS
K925553 11/03/1992 HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 HICHEM DIAGNOSTICS
K925611 11/05/1992 HI CHEM ELECTROLYTE REFERENCE REAGENT HICHEM DIAGNOSTICS
K925612 11/05/1992 HI CHEM ELECTROLYTE BUFFER HICHEM DIAGNOSTICS
K946022 12/12/1994 HICHEM LDH/L REAGENT KIT HICHEM DIAGNOSTICS
K946192 12/20/1994 HICHEM Y-GT REAGENT KIT HICHEM DIAGNOSTICS


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