Harleco - FDA 510(k) Cleared Devices
116
Total
116
Cleared
0
Denied
105 devices
Cleared
Feb 12, 1982
ULTRAZYME PLUS GAMMA GT(65055-65056)
Chemistry
15d
Cleared
Dec 31, 1981
ULTRACHEM GLUC-DH
Chemistry
24d
Cleared
Nov 10, 1981
ULTRACHEM TP, ITEM #64974
Chemistry
13d
Cleared
Nov 10, 1981
ULTRACHEM E-CHOL, ITEM #65025
Chemistry
13d
Cleared
Nov 10, 1981
ULTRACHEM CA, ITEM #64975
Chemistry
13d
Cleared
Nov 10, 1981
ULTRAZYME-GT, ITEM #64959 & 65032
Chemistry
13d
Cleared
Nov 10, 1981
ULTRACHEM GLUC-DH SET, ITEM #65048
Chemistry
13d
Cleared
Nov 10, 1981
ULTRACHEM CREA ITEM #64972
Chemistry
13d
Cleared
Nov 10, 1981
ULTRACHEM ALB, ITEM #64970
Chemistry
13d
Cleared
Oct 02, 1981
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
Chemistry
21d
Cleared
Oct 02, 1981
ULTRA ZYME PLUS AMYL #64982 & 65031
Chemistry
21d
Cleared
Sep 29, 1981
ULTRA CHEM E-GLU #64976 & 65040
Chemistry
18d
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