Biotrol, USA, Inc. - FDA 510(k) Cleared Devices
46
Total
46
Cleared
0
Denied
42 devices
Cleared
Feb 02, 1988
BIOTROL CALIBRANT LEVEL 1
Chemistry
35d
Cleared
Feb 02, 1988
BIOTROL CALIBRANT LEVEL 3
Chemistry
35d
Cleared
Feb 01, 1988
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
Chemistry
34d
Cleared
Jan 07, 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
Chemistry
48d
Cleared
Jan 05, 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
Chemistry
43d
Cleared
Jan 05, 1988
BIOTROL BICARBONATE (CO2) UV HP)
Chemistry
34d
Cleared
Sep 08, 1987
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
Chemistry
28d
Cleared
Sep 04, 1987
BIOTROL ALPHA AMYLASE
Chemistry
49d
Cleared
Sep 02, 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
Chemistry
23d
Cleared
Sep 02, 1987
BIOTROL REFERENCE
Chemistry
23d
Cleared
Sep 02, 1987
BIOTROL MAGNESIUM CALMAGITE
Chemistry
21d
Cleared
Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
Chemistry
21d
Cleared
Aug 26, 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
Chemistry
43d
Cleared
Aug 26, 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
Chemistry
43d
Cleared
Aug 21, 1987
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
Chemistry
25d
Cleared
Aug 13, 1987
BIOTROL AST/TGO MONOREACTIF
Chemistry
27d
Cleared
Aug 13, 1987
BIOTROL ALT/TGP MONOREACTIF
Chemistry
27d