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Hichem Diagnostics — Predicate Candidate Screening

41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time

131 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K981794	HICHEM CALCIUM REAGENT KIT	Hichem Diagnostics	1998-07-29	69
K963383	HICHEM ALP/AMP REAGENT KIT	Hichem Diagnostics	1996-09-23	27
K953860	HICHEM ISE DILUENT KIT 70008	Hichem Diagnostics	1995-09-06	20
K953861	HICHEM ISE INTDERNAL REFERENCE KIT 70009	Hichem Diagnostics	1995-09-06	20
K953863	HICHEM ISE STANDARDS KIT 70011	Hichem Diagnostics	1995-09-06	20
K953862	HICHEM ISEKCI SOLUTION KIT 70010	Hichem Diagnostics	1995-09-06	20
K951751	HICHEM AST REAGENT KIT	Hichem Diagnostics	1995-08-02	107
K946192	HICHEM Y-GT REAGENT KIT	Hichem Diagnostics	1995-05-02	133
K946022	HICHEM LDH/L REAGENT KIT	Hichem Diagnostics	1995-02-23	73
K941433	HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH	Hichem Diagnostics	1994-08-02	131
K925551	HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807	Hichem Diagnostics	1993-04-20	168
K925612	HI CHEM ELECTROLYTE BUFFER	Hichem Diagnostics	1993-04-20	166
K925550	HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806	Hichem Diagnostics	1993-04-20	168
K925611	HI CHEM ELECTROLYTE REFERENCE REAGENT	Hichem Diagnostics	1993-02-23	110
K925553	HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813	Hichem Diagnostics	1993-02-12	101
K925552	HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812	Hichem Diagnostics	1993-02-12	101
K913792	HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL	Hichem Diagnostics	1991-09-25	33
K911803	HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED	Hichem Diagnostics	1991-05-15	22
K904099	URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS	Hichem Diagnostics	1990-10-26	50
K904293	HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)	Hichem Diagnostics	1990-10-12	23
K903888	HI CHEM PROTEIN/LIPIDS LINEARITY	Hichem Diagnostics	1990-09-27	36
K902321	HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)	Hichem Diagnostics	1990-06-28	36
K902155	HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)	Hichem Diagnostics	1990-06-12	28
K901115	MULTICONSTITUENT SERUM RANGE LINEARITY #88234	Hichem Diagnostics	1990-04-19	41
K895555	MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)	Hichem Diagnostics	1989-12-22	107
K895585	HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)	Hichem Diagnostics	1989-11-13	59
K895135	HI CHEM CALIBRATOR A+	Hichem Diagnostics	1989-10-23	68
K890671	HI CHEM CREATININE REAGENT (PRODUCT #88809)	Hichem Diagnostics	1989-05-09	89
K890773	HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196	Hichem Diagnostics	1989-04-18	62
K890584	HI CHEM CALCIUM REAGENT #88808	Hichem Diagnostics	1989-04-10	63
K890990	EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE	Hichem Diagnostics	1989-04-10	42
K890583	HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2	Hichem Diagnostics	1989-03-13	35
K890578	HI CHEM WASH CONCENTRATE REAGENT #88805	Hichem Diagnostics	1989-03-10	32
K890184	MODIFIED INTENDED USE OF CLEANING REAGENT KIT	Hichem Diagnostics	1989-02-07	20
K890183	MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.	Hichem Diagnostics	1989-02-07	20
K883844	HI CHEM KINETIC CHOLESTEROL REAGENT #88218	Hichem Diagnostics	1988-10-31	49
K883404	URIC ACID REAGENT (PRODUCT #88219)	Hichem Diagnostics	1988-09-13	33
K883405	TRIGLYCERIDES REAGENT (PRODUCT #88218)	Hichem Diagnostics	1988-09-13	33
K881437	CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS	Hichem Diagnostics	1988-07-06	92
K881438	UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN	Hichem Diagnostics	1988-07-06	92
K881436	SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS	Hichem Diagnostics	1988-06-02	58

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda