Thermofisher Scientific OY - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thermofisher Scientific OY Chemistry ✕
8 devices
Cleared
Jun 28, 2011
INDIKO
Chemistry
174d
Cleared
May 29, 2008
UREA/BUN, SCAL, NORTROL, ABTROL
Chemistry
188d
Cleared
May 23, 2008
URIC ACID (AOX), SCAL, NORTROL, ABTROL
Chemistry
154d
Cleared
Feb 28, 2008
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
Chemistry
107d
Cleared
Feb 28, 2008
CALCIUM, SCAL, NORTROL, ABTROL
Chemistry
91d
Cleared
Dec 03, 2007
CREATININE (ENZYMATIC)
Chemistry
252d
Cleared
Oct 05, 2007
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
Chemistry
144d
Cleared
Oct 03, 2007
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
Chemistry
117d