Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Hi Chem, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time

64 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days
K960084	HICHEM GLUCOSE/HK REAGENT KIT	Hi Chem, Inc.	1996-04-04	84
K951818	HICHEM ALT REAGENT KIT	Hi Chem, Inc.	1995-05-15	25
K943684	HICHEM ENZYME VERIFIER KIT	Hi Chem, Inc.	1994-10-04	67
K941764	HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808	Hi Chem, Inc.	1994-05-13	45
K902673	HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND	Hi Chem, Inc.	1990-07-17	29
K863617	ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)	Hi Chem, Inc.	1986-10-24	38
K862027	LDP REAGENT CARTRIDGE (NO. 88216)	Hi Chem, Inc.	1986-06-13	16
K861893	GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)	Hi Chem, Inc.	1986-06-05	20
K861879	CK REAGENT CARTRIDGE (PRODUCT NO. 88213)	Hi Chem, Inc.	1986-05-29	14
K861284	AP REAGENT CARTRIDGE	Hi Chem, Inc.	1986-04-28	21
K861283	AST REAGENT CARTRIDGE	Hi Chem, Inc.	1986-04-28	21
K861419	HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE	Hi Chem, Inc.	1986-04-28	13
K861231	ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)	Hi Chem, Inc.	1986-04-28	27
K855196	CLEANING REAGENT KIT PRODUCT NO 88194	Hi Chem, Inc.	1986-01-22	27
K852867	HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE	Hi Chem, Inc.	1985-08-29	52
K853003	HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193	Hi Chem, Inc.	1985-08-06	21
K851350	ION 2 REAGENT KI	Hi Chem, Inc.	1985-04-29	25
K850405	CALIBRATOR B 88133	Hi Chem, Inc.	1985-04-01	56
K842449	HICHEM ION 2/4 SERUM RANGE CALIBRATOR	Hi Chem, Inc.	1984-08-16	55
K842450	HICHEM ION 2/4 URINE RANGE CALIBRATOR	Hi Chem, Inc.	1984-08-16	55
K842025	ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL	Hi Chem, Inc.	1984-06-22	35
K841572	DIRECT BILIRUBIN REAGENT	Hi Chem, Inc.	1984-05-16	29
K833159	POTASSIUM ELECTRODE TIP ASSAMBLY-K-	Hi Chem, Inc.	1983-11-25	70
K831295	AMYLASE REAGENT #88129	Hi Chem, Inc.	1983-06-30	71
K830714	TOTAL BILIRUBIN REAGENT	Hi Chem, Inc.	1983-04-06	29
K830137	CALIBRATOR A	Hi Chem, Inc.	1983-02-07	25
K821225	ALBUMIN REAGENT	Hi Chem, Inc.	1982-05-21	24
K820090	ASTRA-T CALCIUM REAGENT	Hi Chem, Inc.	1982-01-28	15
K813536	ASTRA TOTAL PROTEIN REAGENT	Hi Chem, Inc.	1981-12-31	13
K813370	ELECTROLYTE GEL	Hi Chem, Inc.	1981-12-22	22
K812700	URICAR	Hi Chem, Inc.	1981-11-05	43
K802264	WASH SOLUTION KIT, #88102	Hi Chem, Inc.	1980-10-31	45
K802392	ASTRA PRINTER PAPER #88112-CHLORIDE SILV	Hi Chem, Inc.	1980-10-23	21
K801892	KLINAR REAGENT PAK, #36010	Hi Chem, Inc.	1980-10-23	76
K800616	BUN REAGENT KIT #88108	Hi Chem, Inc.	1980-04-10	23
K791365	FAST FLOW #60310	Hi Chem, Inc.	1979-09-27	64
K791695	CONTRO I	Hi Chem, Inc.	1979-09-24	55
K791696	CONTRO II	Hi Chem, Inc.	1979-09-24	55
K791690	CHOLORDE REAGENT	Hi Chem, Inc.	1979-09-17	48
K791692	SODIUM/POTASSIUM BUFFER SOLUTION	Hi Chem, Inc.	1979-09-17	48
K791685	GLUCOSE REAGENT	Hi Chem, Inc.	1979-09-17	48
K791691	SODIUM/POTASSIUM CONDITIONING SOLUTION	Hi Chem, Inc.	1979-09-17	48
K791693	CALIBRATOR I	Hi Chem, Inc.	1979-09-17	48
K791688	ALKALINE BUFFER	Hi Chem, Inc.	1979-09-17	48
K791694	CALIBRATOR II	Hi Chem, Inc.	1979-09-17	48
K791687	CO2 REFERENCE REAGENT	Hi Chem, Inc.	1979-09-17	48
K791686	CO2 CUP REAGENT	Hi Chem, Inc.	1979-09-17	48
K791689	PICRIC SOLUTION	Hi Chem, Inc.	1979-09-17	48
K782094	HILAR	Hi Chem, Inc.	1979-01-17	34
K781132	CHEMLAR	Hi Chem, Inc.	1978-08-10	38

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