Medical Device Manufacturer · FI , Vantaa

Thermofisher Scientific OY - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2007

Recent clearances: INDIKO, UREA/BUN, SCAL, NORTROL, ABTROL, URIC ACID (AOX), SCAL, NORTROL, ABTROL

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Thermofisher Scientific OY Chemistry ✕

8 devices

1-8 of 8

Cleared Jun 28, 2011

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