FDA.reportPublic FDA data

510(k) K252431

Device
Elecsys Calcitonin
Applicant
Roche Diagnostics GmbH
510(k) number
K252431
Product code
JKR
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2025-08-01
Regulation
862.1140
Classification name
Radioimmunoassay, Calcitonin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Eva Jad
Address
Sandhofer Strasse 116 Mannheim DE 68305 68305

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JKR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited2018-12-21
K132828ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3Roche Diagnostics2013-12-04
K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)Scantibodies Laboratory, Inc.2006-08-30
K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCLDiagnostic Products Corp.2002-12-09
K990073CALCITONINKmi Diagnostics, Inc.1999-05-11
K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITSangui Biotech, Inc.1998-09-03
K964635NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KITNichols Institute Diagnostics1997-05-21
K961043SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)Scantibodies Laboratory, Inc.1996-05-06
K945961CALCITONIN IMMUNOASSAY KITNichols Institute Diagnostics1995-11-20
K951708ELSA-HCTCis-Us, Inc.1995-09-05
K914429DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)Diagnostic Systems Laboratories, Inc.1992-01-15
K912536CALCITONIN KIT MITSUBISHI YUKAMitsubishi Yuka America, Inc.1991-07-18
K874087MODIFIED CALCITONIN RIA KIT DSL #1200Diagnostic Systems Laboratories, Inc.1988-02-02
K872880CALCITONIN RIA KITEndocrine Associates, Inc.1987-08-13
K861274DOUBLE ANTIBODY CALCITONIN RIA KITDiagnostic Products Corp.1986-06-25