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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-11 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K151529.

When was Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator approved by the FDA?

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

What company makes 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 manufactured by Siemens Healthcare Diagnostics, Inc..

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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Related Devices (Code: CDZ)

K153577FREND Testosterone Test SystemNanoentek USA, Inc. K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve MaterialSiemens Healthcare Diagnostics, Inc. K152185ARCHITECT SHBGBiokit, S.A. K181017Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. K191350ACTIVE® Free Testosterone RIAImmunotech S.R.O. K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.

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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