Medical Device Manufacturer · IT , Rome

Sentinel Ch. Srl - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2005

Recent clearances: SENTINEL PANCREATIC AMYLASE, SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY, SENTINEL UIBC LIQUID

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sentinel Ch. Srl Chemistry ✕

8 devices

1-8 of 8

Cleared May 23, 2007

MODIFICATION TO SENTINEL CLIN CHEM CAL

Chemistry · 47d

Cleared Jan 26, 2006

SENTINEL PANCREATIC AMYLASE

Chemistry · 238d

Cleared Nov 25, 2005

SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

Chemistry · 207d

Cleared Nov 17, 2005

SENTINEL UIBC LIQUID

Chemistry · 199d

Cleared Oct 25, 2005

SENTINEL CLIN CHEM CAL

Chemistry · 145d

Cleared Aug 25, 2005

SENTINEL IRON LIQUID

Chemistry · 115d

Cleared Aug 08, 2005

CRP DIAGNOSTIC ASSAY

Chemistry · 129d

Cleared Jul 25, 2005

SENTINEL PLASMAPROTEINS CAL 3X

Chemistry · 53d