ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487

Test, Cystatin C

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/n 04851534, P/n 10376487.

Pre-market Notification Details

• Device ID: K083906
• 510k Number: K083906
• Device Name: ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
• Classification: Test, Cystatin C
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591
• Contact: Kira Gordon
• Correspondent: Kira Gordon; SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591
• Product Code: NDY
• CFR Regulation Number: 862.1225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-30
• Decision Date: 2009-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414561578	K083906	000
00630414557915	K083906	000
05055273208665	K083906	000
05055273207439	K083906	000
00630414597522	K083906	000
00630414595573	K083906	000