Medical Device Manufacturer · US , Mchenry , IL

Hi Chem, Inc. - FDA 510(k) Cleared Devices

52 submissions · 52 cleared · Since 1977
52
Total
52
Cleared
0
Denied
50 devices
26-50 of 50
Cleared Feb 07, 1983
CALIBRATOR A
K830137 · JIS
Chemistry · 25d
Cleared May 21, 1982
ALBUMIN REAGENT
K821225 · CIX
Chemistry · 24d
Cleared Jan 28, 1982
ASTRA-T CALCIUM REAGENT
K820090 · CIC
Chemistry · 15d
Cleared Dec 31, 1981
ASTRA TOTAL PROTEIN REAGENT
K813536 · CEK
Chemistry · 13d
Cleared Dec 22, 1981
ELECTROLYTE GEL
K813370 · CGA
Chemistry · 22d
Cleared Nov 05, 1981
URICAR
K812700 · KNK
Chemistry · 43d
Cleared Oct 31, 1980
WASH SOLUTION KIT, #88102
K802264 · JJF
Chemistry · 45d
Cleared Oct 23, 1980
KLINAR REAGENT PAK, #36010
K801892 · JGT
Chemistry · 76d
Cleared Oct 23, 1980
ASTRA PRINTER PAPER #88112-CHLORIDE SILV
K802392 · JJF
Chemistry · 21d
Cleared Apr 10, 1980
BUN REAGENT KIT #88108
K800616 · CDS
Chemistry · 23d
Cleared Sep 24, 1979
CONTRO I
K791695 · JJY
Chemistry · 55d
Cleared Sep 24, 1979
CONTRO II
K791696 · JJY
Chemistry · 55d
Cleared Sep 17, 1979
GLUCOSE REAGENT
K791685 · CGA
Chemistry · 48d
Cleared Sep 17, 1979
CO2 CUP REAGENT
K791686 · JFL
Chemistry · 48d
Cleared Sep 17, 1979
CO2 REFERENCE REAGENT
K791687 · JFL
Chemistry · 48d
Cleared Sep 17, 1979
ALKALINE BUFFER
K791688 · CGX
Chemistry · 48d
Cleared Sep 17, 1979
PICRIC SOLUTION
K791689 · CGX
Chemistry · 48d
Cleared Sep 17, 1979
CHOLORDE REAGENT
K791690 · JFS
Chemistry · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM CONDITIONING SOLUTION
K791691 · JGS
Chemistry · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM BUFFER SOLUTION
K791692 · CEM
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR I
K791693 · JIX
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR II
K791694 · JIX
Chemistry · 48d
Cleared Aug 10, 1978
CHEMLAR
K781132 · JFS
Chemistry · 38d
Cleared Oct 25, 1977
CHOLAR PRODU&T #17010
K771731 · CHH
Chemistry · 41d
Cleared Jul 15, 1977
TRENDAR
K771000 · CGA
Chemistry · 42d
Filters