Harleco - FDA 510(k) Cleared Devices
116
Total
116
Cleared
0
Denied
116 devices
Cleared
Dec 06, 1977
ULTRACHEM PHOSPHORUS, 64973
Chemistry
20d
Cleared
Dec 06, 1977
CREATININE, 64972
Chemistry
20d
Cleared
Nov 28, 1977
CREATININE URINE APPLI.-#32308
Chemistry
21d
Cleared
Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
Chemistry
21d
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
Nov 02, 1977
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
Pathology
19d
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
Aug 22, 1977
HISTOCHEMICAL AFB DEMONSTRATION
Pathology
26d
Cleared
Aug 22, 1977
HISTOCHEMICAL FERRIC IRON SET
Hematology
14d
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
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