Harleco - FDA 510(k) Cleared Devices
116
Total
116
Cleared
0
Denied
105 devices
Cleared
Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
Chemistry
21d
Cleared
Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
Chemistry
21d
Cleared
Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
Chemistry
21d
Cleared
Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
Chemistry
19d
Cleared
Nov 15, 1977
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
Chemistry
19d
Cleared
Nov 14, 1977
IRON SET, ITEM NO. 65008
Chemistry
31d
Cleared
Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
Chemistry
31d
Cleared
Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
Chemistry
18d
Cleared
Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
Chemistry
18d
Cleared
Nov 11, 1977
TOTAL PROTEIN SET, ITEM NO. 64010
Chemistry
28d
Cleared
Oct 18, 1977
GLUCOSE REAGENT FOR GLUC. ANALYZER
Chemistry
32d
Cleared
Oct 14, 1977
CLINICARD CREATININE CHEMISTRY
Chemistry
25d
Cleared
Sep 02, 1977
AMYLASE ULTRAZYME PLUS
Chemistry
37d
Cleared
Sep 02, 1977
CK-1 ULTRAZYME PLUS
Chemistry
37d
Cleared
Jul 21, 1977
UNIPAK BUN
Chemistry
35d
Cleared
Jul 21, 1977
UNIPAK URIC ACID
Chemistry
35d
Cleared
Jul 21, 1977
UNIPAK TOTAL BILIRUBIN
Chemistry
35d
Cleared
Jul 21, 1977
UNIPAK GLUCOSE
Chemistry
35d
Cleared
Jul 21, 1977
UNIPAK TOTAL & DIRECT BILIRUBIN
Chemistry
35d
Cleared
Jul 21, 1977
UNIPAK CHOLESTEROL
Chemistry
35d
Cleared
Jul 21, 1977
UNIPAK ALBUMIN
Chemistry
35d
Cleared
Jul 21, 1977
CLINICARD UV AMYLASE CHEMISTRY
Chemistry
28d
Cleared
Jul 14, 1977
ULTRAZYME PLUS ALP
Chemistry
62d
Cleared
Jul 14, 1977
ULTRAZYME PLUS HBD
Chemistry
62d
Cleared
Jul 14, 1977
ULTRAZYME PLUS GPT
Chemistry
59d
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