Medical Device Manufacturer · AU , Noble Park

Thermo-Electron Corp. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2005

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Thermo-Electron Corp. Chemistry ✕

3 devices

1-3 of 3

Cleared Mar 23, 2007

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401

Chemistry · 305d

Cleared Mar 16, 2007

OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

Chemistry · 200d

Cleared Sep 23, 2005

DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM

Chemistry · 56d