Home / 510(k) Clearances / K190121

510(k) K190121

IDS SHBG by Immunodiagnostic Systems , Ltd. — Product Code CDZ

K190121 is an FDA 510(k) premarket notification submitted by Immunodiagnostic Systems , Ltd. for the device "IDS SHBG". The FDA issued a decision of Substantially Equivalent on June 17, 2019. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Immunodiagnostic Systems , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2019
Date Received
January 25, 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

Other clearances by Immunodiagnostic Systems , Ltd.

  • K202136 — IDS Cortisol (April 13, 2021)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • K161158 — IDS-iSYS Intact PTHN (January 31, 2017)
  • K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (November 15, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K142351 — 25-Hydroxy Vitamin Ds EIA (August 25, 2015)
  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • K143324 — IDS-iSYS CTX-I Calibration Verifiers (March 30, 2015)
  • K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (December 19, 2014)
  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)

Other clearances for product code CDZ

  • K252728 — IDS-iSYS Total Testosterone (April 15, 2026)
  • 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)
  • K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (August 28, 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