Medical Device Manufacturer · US , Brea , CA

Hichem Diagnostics

41 submissions · 41 cleared · Since 1988
41
Total
41
Cleared
0
Denied

Hichem Diagnostics — FDA 510(k) Submissions

Hichem Diagnostics has submitted 41 FDA 510(k) premarket notifications since 1988, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Calibrator, Multi-analyte Mixture, Electrode, Ion-specific, Chloride, Ph Rate Measurement, Carbon-dioxide, Azo Dye, Calcium . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
HICHEM CALCIUM REAGENT KIT
K981794 · CJY Azo Dye, Calcium · Chemistry
Jul 1998 69d
HICHEM ALP/AMP REAGENT KIT
K963383 · CKF Phenylphosphate, Alkaline... · Chemistry
Sep 1996 27d
HICHEM ISE DILUENT KIT 70008
K953860 · CGZ Electrode, Ion-specific,... · Chemistry
Sep 1995 20d
HICHEM ISE INTDERNAL REFERENCE KIT 70009
K953861 · CGZ Electrode, Ion-specific,... · Chemistry
Sep 1995 20d
HICHEM ISEKCI SOLUTION KIT 70010
K953862 · CGZ Electrode, Ion-specific,... · Chemistry
Sep 1995 20d
HICHEM ISE STANDARDS KIT 70011
K953863 · JIX Calibrator, Multi-analyte... · Chemistry
Sep 1995 20d
HICHEM AST REAGENT KIT
K951751 · CIT Nadh Oxidation/nad... · Chemistry
Aug 1995 107d
HICHEM Y-GT REAGENT KIT
K946192 · JQB Kinetic Method,... · Chemistry
May 1995 133d
HICHEM LDH/L REAGENT KIT
K946022 · CFJ Nad Reduction/nadh... · Chemistry
Feb 1995 73d
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433 · JJX Single (specified)... · Chemistry
Aug 1994 131d
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
K925550 · CDS Electrode, Ion Specific,... · Chemistry
Apr 1993 168d
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · CGA Glucose Oxidase, Glucose · Chemistry
Apr 1993 168d
HI CHEM ELECTROLYTE BUFFER
K925612 · JGS Electrode, Ion Specific,... · Chemistry
Apr 1993 166d
HI CHEM ELECTROLYTE REFERENCE REAGENT
K925611 · JGS Electrode, Ion Specific,... · Chemistry
Feb 1993 110d
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · JFL Ph Rate Measurement,... · Chemistry
Feb 1993 101d
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553 · JFL Ph Rate Measurement,... · Chemistry
Feb 1993 101d
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
K913792 · JJX Single (specified)... · Chemistry
Sep 1991 33d
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
K911803 · JJY Multi-analyte Controls,... · Chemistry
May 1991 22d
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099 · JJY Multi-analyte Controls,... · Chemistry
Oct 1990 50d
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293 · JJY Multi-analyte Controls,... · Chemistry
Oct 1990 23d
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · JIX Calibrator, Multi-analyte... · Chemistry
Sep 1990 36d
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · JJT Enzyme Controls (assayed... · Chemistry
Jun 1990 36d
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
K902155 · JIM Method, Metallic... · Chemistry
Jun 1990 28d
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115 · JJY Multi-analyte Controls,... · Chemistry
Apr 1990 41d
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · CJA Amyloclastic, Amylase · Chemistry
Dec 1989 107d
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