DIMENSION CLINICAL CHEMISTRY SYSTEM

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Clinical Chemistry System.

Pre-market Notification Details

• Device ID: K112999
• 510k Number: K112999
• Device Name: DIMENSION CLINICAL CHEMISTRY SYSTEM
• Classification: Analyzer, Chemistry (photometric, Discrete), For Clinical Use
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101 MIALSTOP 514 Newark, DE 19714 -6101
• Contact: Lorraine H Piestrak
• Correspondent: Lorraine H Piestrak; SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101 MIALSTOP 514 Newark, DE 19714 -6101
• Product Code: JJE
• Subsequent Product Code: CEM
• Subsequent Product Code: CEW
• Subsequent Product Code: CFR
• Subsequent Product Code: CGZ
• Subsequent Product Code: CIT
• Subsequent Product Code: JGS
• CFR Regulation Number: 862.2160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-07
• Decision Date: 2011-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768014291	K112999	000
00842768013805	K112999	000
00842768005558	K112999	000
00842768005541	K112999	000