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510(k) K191350

ACTIVE® Free Testosterone RIA by Immunotech S.R.O. — Product Code CDZ

K191350 is an FDA 510(k) premarket notification submitted by Immunotech S.R.O. for the device "ACTIVE® Free Testosterone RIA". The FDA issued a decision of Substantially Equivalent on December 20, 2019. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
May 20, 2019
Clearance Type
Special
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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  • K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (August 28, 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)

FDA data resources