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FDA 510(k)

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

K-Number: K191533 · 2019-08-28

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-08-28
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-08-28 under approval number K191533. 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 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG?

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K191533.

When was ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG approved by the FDA?

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG received FDA 510(k) clearance on 2019-08-28, under approval number K191533.

What company makes ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG?

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG?

The FDA product code for ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG is CDZ.

Other Devices by Siemens Healthcare Diagnostics, Inc.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161964ADVIA Centaur HAV IgM Assay K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator 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 Material K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

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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. K151529Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone CalibratorSiemens Healthcare Diagnostics, Inc. K181017Free Testosterone AccuBind ELISA Test SystemMonobind, Inc. K191350ACTIVE® Free Testosterone RIAImmunotech S.R.O.

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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