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510(k) K924289

Device
KALLESTAD RSV MICROPLATE EIA
Applicant
BIO-RAD LABORATORIES, INC.
510(k) number
K924289
Product code
MCE  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-12
Date received
1992-08-21
Regulation
866.3480
Classification name
Respiratory Syncytial Virus - Elisa
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHERI W FINK
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 MCE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061008QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199Quidel Corp.2006-09-08

Legacy Summary#

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FDA Review#

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