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510(k) K951708

Device
ELSA-HCT
Applicant
CIS-US, INC.
510(k) number
K951708
Product code
JKR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-05
Date received
1995-04-13
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
No

Applicant Contact#

Contact
MARY E DONOVAN
Address
10 De Angelo Dr. Bedford MA US 01730 01730

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
K252431Elecsys CalcitoninRoche Diagnostics GmbH2026-04-24
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
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

Legacy Summary#

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FDA Review#

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