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510(k) K161158

IDS-iSYS Intact PTHN by Immunodiagnostic Systems , Ltd. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2017
Date Received
April 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Immunodiagnostic Systems , Ltd.

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  • 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)

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  • K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (September 5, 2023)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (May 23, 2017)
  • K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration (June 22, 2015)
  • K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (February 5, 2014)
  • K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (November 8, 2013)
  • K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (March 21, 2013)
  • K103325 — IDS-ISYS INTACT PTH (February 3, 2012)