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FDA 510(k)

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

K-Number: K151529 · 2016-02-11

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-02-11
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone 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 2016-02-11 under 510(k) number K151529. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator?

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K151529.

When did Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator receive FDA 510(k) clearance?

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator received FDA 510(k) clearance on 2016-02-11, under 510(k) number K151529.

Who is the listed applicant for Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone 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 Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator?

The FDA product code for Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator is CDZ.

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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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