FDA.reportPublic FDA data

510(k) K232791

Device
Access Intact PTH
Applicant
Beckman Coulter, Inc.
510(k) number
K232791
Product code
CEW
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-01
Date received
2023-09-11
Regulation
862.1545
Classification name
Radioimmunoassay, Parathyroid Hormone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neha Desai
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CEW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics2024-03-22
K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics2023-09-05
K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.2019-08-30
K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.2017-05-23
K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.2017-01-31
K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc.2015-06-22
K133601ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics, Inc.2014-02-05
K132515LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERSDiaSorin, Inc.2013-11-08
K121981ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics2013-03-21
K103325IDS-ISYS INTACT PTHImmunodiagnostic Systems , Ltd.2012-02-03
K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITOrtho-Clinical Diagnostics2010-10-22
K070709ROCHE ELECSYS PTH TEST SYSTEMRoche Diagnostics Corp.2007-07-13
K063605ST AIA-PACK INTACT PTH ASSAYTosoh Bioscience, Inc.2007-06-21
K063232ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01Biokit, S.A.2007-06-19
K070391ELECSYS PTH TEST SYSTEMRoche Diagnostics Corp.2007-03-20