Hi Chem, Inc. - FDA 510(k) Cleared Devices
52
Total
52
Cleared
0
Denied
50 devices
Cleared
Feb 07, 1983
CALIBRATOR A
Chemistry
25d
Cleared
May 21, 1982
ALBUMIN REAGENT
Chemistry
24d
Cleared
Jan 28, 1982
ASTRA-T CALCIUM REAGENT
Chemistry
15d
Cleared
Dec 31, 1981
ASTRA TOTAL PROTEIN REAGENT
Chemistry
13d
Cleared
Dec 22, 1981
ELECTROLYTE GEL
Chemistry
22d
Cleared
Nov 05, 1981
URICAR
Chemistry
43d
Cleared
Oct 31, 1980
WASH SOLUTION KIT, #88102
Chemistry
45d
Cleared
Oct 23, 1980
KLINAR REAGENT PAK, #36010
Chemistry
76d
Cleared
Oct 23, 1980
ASTRA PRINTER PAPER #88112-CHLORIDE SILV
Chemistry
21d
Cleared
Apr 10, 1980
BUN REAGENT KIT #88108
Chemistry
23d
Cleared
Sep 24, 1979
CONTRO I
Chemistry
55d
Cleared
Sep 24, 1979
CONTRO II
Chemistry
55d
Cleared
Sep 17, 1979
GLUCOSE REAGENT
Chemistry
48d
Cleared
Sep 17, 1979
CO2 CUP REAGENT
Chemistry
48d
Cleared
Sep 17, 1979
CO2 REFERENCE REAGENT
Chemistry
48d
Cleared
Sep 17, 1979
ALKALINE BUFFER
Chemistry
48d
Cleared
Sep 17, 1979
PICRIC SOLUTION
Chemistry
48d
Cleared
Sep 17, 1979
CHOLORDE REAGENT
Chemistry
48d
Cleared
Sep 17, 1979
SODIUM/POTASSIUM CONDITIONING SOLUTION
Chemistry
48d
Cleared
Sep 17, 1979
SODIUM/POTASSIUM BUFFER SOLUTION
Chemistry
48d
Cleared
Sep 17, 1979
CALIBRATOR I
Chemistry
48d
Cleared
Sep 17, 1979
CALIBRATOR II
Chemistry
48d
Cleared
Aug 10, 1978
CHEMLAR
Chemistry
38d
Cleared
Oct 25, 1977
CHOLAR PRODU&T #17010
Chemistry
41d
Cleared
Jul 15, 1977
TRENDAR
Chemistry
42d