Home / 510(k) Clearances / K163658

510(k) K163658

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay by Siemens Healthcare Diagnostics, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2017
Date Received
December 23, 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 Siemens Healthcare Diagnostics, Inc.

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K242981 — Atellica IM Thyroglobulin (Tg) (June 20, 2025)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code CEW

  • K231927 — Elecsys PTH , Elecsys PTH STAT (March 22, 2024)
  • K232791 — Access Intact PTH (March 1, 2024)
  • K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (September 5, 2023)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K161158 — IDS-iSYS Intact PTHN (January 31, 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)