ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

Cardiac C-reactive Protein, Antigen, Antiserum, And Control

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Chemistry Cardiophase High Sensitivity C-reactive Protein (hscrp), Calibrators.

Pre-market Notification Details

• Device ID: K081294
• 510k Number: K081294
• Device Name: ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
• Classification: Cardiac C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591
• Contact: Philip Liu
• Correspondent: Philip Liu; Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591
• Product Code: NQD
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-05-07
• Decision Date: 2008-07-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414597508	K081294	000
00630414596174	K081294	000
00630414552699	K081294	000
00630414526843	K081294	000