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510(k) K801037

Device
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
Applicant
UNION CARBIDE CORP.
510(k) number
K801037
Product code
LCI  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-28
Date received
1980-05-02
Regulation
862.2050
Classification name
Automated Radioimmunoassay Systems, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K98361725-HYDROXYVITAMIN D 125I RIA KITDiaSorin, Inc.1998-11-16
K780886SYSTEM 6000 AUTOMATED RIA ANALYZERBeckman Instruments, Inc.1978-09-01

Legacy Summary#

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FDA Review#

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