Medical Device Manufacturer · US , Mchenry , IL

Hi Chem, Inc.

52 submissions · 52 cleared · Since 1977
52
Total
52
Cleared
0
Denied

Hi Chem, Inc. — FDA 510(k) Submissions

Hi Chem, Inc. has submitted 52 FDA 510(k) premarket notifications since 1977, of which 52 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Alkaline Picrate, Colorimetry, Creatinine, Electrode, Ion Specific, Sodium, Calibrator, Primary, Electrode, Ion Specific, Potassium, Calibrator, Multi-analyte Mixture . Use the specialty filter in the sidebar to narrow results.

52 devices
1–25 of 52
HICHEM GLUCOSE/HK REAGENT KIT
K960084 · CFR Hexokinase, Glucose · Chemistry
Apr 1996 84d
HICHEM ALT REAGENT KIT
K951818 · CKA Nadh Oxidation/nad... · Chemistry
May 1995 25d
HICHEM ENZYME VERIFIER KIT
K943684 · JJT Enzyme Controls (assayed... · Chemistry
Oct 1994 67d
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · CJY Azo Dye, Calcium · Chemistry
May 1994 45d
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
K902673 · JJY Multi-analyte Controls,... · Chemistry
Jul 1990 29d
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
K863617 · JGS Electrode, Ion Specific,... · Chemistry
Oct 1986 38d
LDP REAGENT CARTRIDGE (NO. 88216)
K862027 · CFJ Nad Reduction/nadh... · Chemistry
Jun 1986 16d
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · JXL Block, Bite · Chemistry
Jun 1986 20d
CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
K861879 · CGS Nad Reduction/nadh... · Chemistry
May 1986 14d
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
K861231 · CKA Nadh Oxidation/nad... · Chemistry
Apr 1986 27d
AST REAGENT CARTRIDGE
K861283 · CIT Nadh Oxidation/nad... · Chemistry
Apr 1986 21d
AP REAGENT CARTRIDGE
K861284 · CJE Nitrophenylphosphate,... · Chemistry
Apr 1986 21d
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
K861419 · CFJ Nad Reduction/nadh... · Chemistry
Apr 1986 13d
CLEANING REAGENT KIT PRODUCT NO 88194
K855196 · JJE Analyzer, Chemistry... · Chemistry
Jan 1986 27d
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
K852867 · CKA Nadh Oxidation/nad... · Chemistry
Aug 1985 52d
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003 · JJE Analyzer, Chemistry... · Chemistry
Aug 1985 21d
ION 2 REAGENT KI
K851350 · CEM Electrode, Ion Specific,... · Chemistry
Apr 1985 25d
CALIBRATOR B 88133
K850405 · JIX Calibrator, Multi-analyte... · Chemistry
Apr 1985 56d
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449 · JIS Calibrator, Primary · Chemistry
Aug 1984 55d
HICHEM ION 2/4 URINE RANGE CALIBRATOR
K842450 · JIS Calibrator, Primary · Chemistry
Aug 1984 55d
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
K842025 · JGS Electrode, Ion Specific,... · Chemistry
Jun 1984 35d
DIRECT BILIRUBIN REAGENT
K841572 · CIG Diazo Colorimetry, Bilirubin · Chemistry
May 1984 29d
POTASSIUM ELECTRODE TIP ASSAMBLY-K-
K833159 · CEM Electrode, Ion Specific,... · Chemistry
Nov 1983 70d
AMYLASE REAGENT #88129
K831295 · KHM Nephelometric, Amylase · Chemistry
Jun 1983 71d
TOTAL BILIRUBIN REAGENT
K830714 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Apr 1983 29d
Filters