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Hichem Diagnostics

FDA 510(k) & PMA Approved Devices — 41 products

Total Devices41
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K981794 HICHEM CALCIUM REAGENT KITCJY1998-07-29 View
510(k) K963383 HICHEM ALP/AMP REAGENT KITCKF1996-09-23 View
510(k) K953863 HICHEM ISE STANDARDS KIT 70011JIX1995-09-06 View
510(k) K953861 HICHEM ISE INTDERNAL REFERENCE KIT 70009CGZ1995-09-06 View
510(k) K953860 HICHEM ISE DILUENT KIT 70008CGZ1995-09-06 View
510(k) K953862 HICHEM ISEKCI SOLUTION KIT 70010CGZ1995-09-06 View
510(k) K951751 HICHEM AST REAGENT KITCIT1995-08-02 View
510(k) K946192 HICHEM Y-GT REAGENT KITJQB1995-05-02 View
510(k) K946022 HICHEM LDH/L REAGENT KITCFJ1995-02-23 View
510(k) K941433 HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGHJJX1994-08-02 View
510(k) K925551 HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807CGA1993-04-20 View
510(k) K925550 HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806CDS1993-04-20 View
510(k) K925612 HI CHEM ELECTROLYTE BUFFERJGS1993-04-20 View
510(k) K925611 HI CHEM ELECTROLYTE REFERENCE REAGENTJGS1993-02-23 View
510(k) K925552 HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812JFL1993-02-12 View
510(k) K925553 HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813JFL1993-02-12 View
510(k) K913792 HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROLJJX1991-09-25 View
510(k) K911803 HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIEDJJY1991-05-15 View
510(k) K904099 URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDSJJY1990-10-26 View
510(k) K904293 HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)JJY1990-10-12 View
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