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510(k) K191533

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG by Siemens Healthcare Diagnostics, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2019
Date Received
June 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

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Other clearances for product code CDZ

  • K240865 — IDS-iSYS Free Testosterone (October 23, 2024)
  • K233480 — Access SHBG (February 8, 2024)
  • K223405 — Access Testosterone (January 13, 2023)
  • K211685 — Elecsys Testosterone II (May 6, 2022)
  • K201908 — LIAISON Testosterone xt (October 15, 2020)
  • K191350 — ACTIVE® Free Testosterone RIA (December 20, 2019)
  • K190121 — IDS SHBG (June 17, 2019)
  • K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay (January 29, 2019)
  • K181017 — Free Testosterone AccuBind ELISA Test System (July 20, 2018)
  • K153577 — FREND Testosterone Test System (October 14, 2016)