FDA 510(k)

DIMENSION CHEMISTRY III CALIBRATORY

K-Number: K123321 · 2013-02-15

Decision Date2013-02-15

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION CHEMISTRY III CALIBRATORY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2013-02-15 under 510(k) number K123321. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION CHEMISTRY III CALIBRATORY?

DIMENSION CHEMISTRY III CALIBRATORY is a medical device that received FDA 510(k) clearance on 2013-02-15. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K123321.

When did DIMENSION CHEMISTRY III CALIBRATORY receive FDA 510(k) clearance?

DIMENSION CHEMISTRY III CALIBRATORY received FDA 510(k) clearance on 2013-02-15, under 510(k) number K123321.

Who is the listed applicant for DIMENSION CHEMISTRY III CALIBRATORY?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION CHEMISTRY III CALIBRATORY?

The FDA product code for DIMENSION CHEMISTRY III CALIBRATORY is JIX.

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Related Devices (Code: JIX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.