Harleco - FDA 510(k) Cleared Devices
116
Total
116
Cleared
0
Denied
116 devices
Cleared
Mar 31, 1981
QUALITROL #65057
Immunology
14d
Cleared
Jan 09, 1981
CARDIO ZYME PLUS CK-MB #65045
Chemistry
25d
Cleared
Jan 09, 1981
CARDIOZYME PLUS CK-TOTAL #65046
Chemistry
25d
Cleared
Jun 22, 1978
SYSING AND HEMOGLOBIN REAGENT
Hematology
34d
Cleared
Jun 14, 1978
ISOTONIC BUFFERED SALINE
Hematology
26d
Cleared
May 19, 1978
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
Chemistry
50d
Cleared
May 19, 1978
ULTRACHEM CREATININE 64972, CENTRIFUCHEM
Chemistry
50d
Cleared
May 19, 1978
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM
Chemistry
50d
Cleared
May 19, 1978
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
Chemistry
49d
Cleared
May 19, 1978
ULTRACHEM T-BILI 64971 GILFORD 3500
Chemistry
49d
Cleared
Mar 09, 1978
ULTRAZYME PLUS GT
Chemistry
48d
Cleared
Mar 09, 1978
ULTRAZYME PLUS CK-1
Chemistry
48d
Cleared
Mar 09, 1978
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
Chemistry
42d
Cleared
Mar 09, 1978
TRIGLYCERIDE INSTRUMENT APPLICATION
Chemistry
35d
Cleared
Feb 14, 1978
ULTRAZYME PLUS LDH
Chemistry
25d
Cleared
Feb 13, 1978
GLUCOSE REAGENT FOR GLUCOSE ANALYZER
Chemistry
26d
Cleared
Feb 13, 1978
IRON BINDING CAPACITY CHEMISTRY
Chemistry
26d
Cleared
Feb 13, 1978
ULTRAZYME PLUS ALP
Chemistry
26d
Cleared
Feb 13, 1978
ULTRAZYME PLUS GPT
Chemistry
24d
Cleared
Feb 13, 1978
ULTRAZYME PLUS GOT
Chemistry
24d
Cleared
Feb 13, 1978
ULTRAZYME PLUS HBD
Chemistry
24d
Cleared
Feb 07, 1978
ULTRACHEM ALBUMIN
Chemistry
20d
Cleared
Feb 01, 1978
ULTRACHEM E-GLU, MANUAL DETERM.
Chemistry
20d
Cleared
Jan 05, 1978
CLINICARD CK-II
Chemistry
27d
Cleared
Dec 06, 1977
ULTRACHEM TOTAL PROTEIN, #64974
Chemistry
20d
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