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FDA 510(k)

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

K-Number: K081789 · 2008-09-10

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2008-09-10
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-09-10 under 510(k) number K081789. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR?

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR is a medical device that received FDA 510(k) clearance on 2008-09-10. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K081789.

When did DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR receive FDA 510(k) clearance?

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR received FDA 510(k) clearance on 2008-09-10, under 510(k) number K081789.

Who is the listed applicant for DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR?

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

What is the FDA product code for DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR?

The FDA product code for DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR is JIT.

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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.

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