Atlas FDA

Hichem Diagnostics

41 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HICHEM CALCIUM REAGENT KIT (K981794)Hichem Diagnostics1998-07-29
HICHEM ALP/AMP REAGENT KIT (K963383)Hichem Diagnostics1996-09-23
HICHEM ISE DILUENT KIT 70008 (K953860)Hichem Diagnostics1995-09-06
HICHEM ISE INTDERNAL REFERENCE KIT 70009 (K953861)Hichem Diagnostics1995-09-06
HICHEM ISE STANDARDS KIT 70011 (K953863)Hichem Diagnostics1995-09-06
HICHEM ISEKCI SOLUTION KIT 70010 (K953862)Hichem Diagnostics1995-09-06
HICHEM AST REAGENT KIT (K951751)Hichem Diagnostics1995-08-02
HICHEM Y-GT REAGENT KIT (K946192)Hichem Diagnostics1995-05-02
HICHEM LDH/L REAGENT KIT (K946022)Hichem Diagnostics1995-02-23
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (K941433)Hichem Diagnostics1994-08-02
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (K925551)Hichem Diagnostics1993-04-20
HI CHEM ELECTROLYTE BUFFER (K925612)Hichem Diagnostics1993-04-20
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (K925550)Hichem Diagnostics1993-04-20
HI CHEM ELECTROLYTE REFERENCE REAGENT (K925611)Hichem Diagnostics1993-02-23
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 (K925553)Hichem Diagnostics1993-02-12
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 (K925552)Hichem Diagnostics1993-02-12
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL (K913792)Hichem Diagnostics1991-09-25
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED (K911803)Hichem Diagnostics1991-05-15
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS (K904099)Hichem Diagnostics1990-10-26
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) (K904293)Hichem Diagnostics1990-10-12
HI CHEM PROTEIN/LIPIDS LINEARITY (K903888)Hichem Diagnostics1990-09-27
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) (K902321)Hichem Diagnostics1990-06-28
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) (K902155)Hichem Diagnostics1990-06-12
MULTICONSTITUENT SERUM RANGE LINEARITY #88234 (K901115)Hichem Diagnostics1990-04-19
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (K895555)Hichem Diagnostics1989-12-22
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) (K895585)Hichem Diagnostics1989-11-13
HI CHEM CALIBRATOR A+ (K895135)Hichem Diagnostics1989-10-23
HI CHEM CREATININE REAGENT (PRODUCT #88809) (K890671)Hichem Diagnostics1989-05-09
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 (K890773)Hichem Diagnostics1989-04-18
HI CHEM CALCIUM REAGENT #88808 (K890584)Hichem Diagnostics1989-04-10
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE (K890990)Hichem Diagnostics1989-04-10
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 (K890583)Hichem Diagnostics1989-03-13
HI CHEM WASH CONCENTRATE REAGENT #88805 (K890578)Hichem Diagnostics1989-03-10
MODIFIED INTENDED USE OF CLEANING REAGENT KIT (K890184)Hichem Diagnostics1989-02-07
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. (K890183)Hichem Diagnostics1989-02-07
HI CHEM KINETIC CHOLESTEROL REAGENT #88218 (K883844)Hichem Diagnostics1988-10-31
URIC ACID REAGENT (PRODUCT #88219) (K883404)Hichem Diagnostics1988-09-13
TRIGLYCERIDES REAGENT (PRODUCT #88218) (K883405)Hichem Diagnostics1988-09-13
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS (K881437)Hichem Diagnostics1988-07-06
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN (K881438)Hichem Diagnostics1988-07-06
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS (K881436)Hichem Diagnostics1988-06-02

Track Hichem Diagnostics automatically

Every clearance here is in the API, with alerts when new ones post.