ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)

Azo Dye, Calcium

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Calcium_2 (ca_2) Method, Models P/m 02189699 (40 Ml Fill), P/n 02189915 (70 Ml Fill).

Pre-market Notification Details

• Device ID: K083386
• 510k Number: K083386
• Device Name: ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
• Classification: Azo Dye, Calcium
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591
• Contact: Carol Bianca
• Correspondent: Carol Bianca; SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591
• Product Code: CJY
• CFR Regulation Number: 862.1145 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-17
• Decision Date: 2009-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414553160	K083386	000
00630414513102	K083386	000
00630414513096	K083386	000
00630414220697	K083386	000