CRP Vario

Cardiac 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: K173833
• 510k Number: K173833
• Device Name: CRP Vario
• Classification: Cardiac 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: NQD
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-12-18
• Decision Date: 2018-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740158507	K173833	000
00380740158491	K173833	000