Home / 510(k) Clearances / K221197

510(k) K221197

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack by Ortho Clinical Diagnostics — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2023
Date Received
April 25, 2022
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 Ortho Clinical Diagnostics

  • K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack (August 28, 2024)
  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack (August 23, 2023)
  • K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (August 9, 2023)
  • K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack (December 12, 2022)
  • K213626 — VITROS AFP (June 15, 2022)
  • K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack (January 28, 2022)
  • K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (October 4, 2021)
  • K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators (February 25, 2020)
  • K163433 — VITROS Chemistry Products GLU Slides (September 18, 2017)

Other clearances for product code CEW

  • K231927 — Elecsys PTH , Elecsys PTH STAT (March 22, 2024)
  • K232791 — Access Intact PTH (March 1, 2024)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (May 23, 2017)
  • 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)