CRP Vario

C-reactive Protein, Antigen, Antiserum, And Control

Sentinel CH, Spa

The following data is part of a premarket notification filed by Sentinel Ch, Spa with the FDA for Crp Vario.

Pre-market Notification Details

• Device ID: K192118
• 510k Number: K192118
• Device Name: CRP Vario
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: Sentinel CH, Spa Via Robert Koch, 2 Milano, IT 20152
• Contact: Patricia Dupe
• Correspondent: Patricia Dupe; Sentinel CH, Spa Via Robert Koch, 2 Milano, IT 20152
• Product Code: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-06
• Decision Date: 2019-11-08