Cleared Special

K112999 - DIMENSION CLINICAL CHEMISTRY SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K112999 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
46d
Days
Class 1
Risk

K112999 is an FDA 510(k) clearance for the DIMENSION CLINICAL CHEMISTRY SYSTEM. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K112999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2011
Decision Date November 22, 2011
Days to Decision 46 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.