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510(k) K875101

Device
VIROGEN CMV ANTIBODY TEST
Applicant
WAMPOLE LABORATORIES
510(k) number
K875101
Product code
LQO  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-01
Date received
1987-12-10
Regulation
866.3110
Classification name
Dna-reagents, Campylobacter Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANN MACLEARIE
Address
P.O. Box # 1 Cranbury NJ US 08512 08512

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LQO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K894712ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATIONGen-Probe, Inc.1989-11-14
K873670SNAP CAMPYLOBACTOR DIAGNOSTIC KITMolecular Biosystems, Inc.1988-06-08
K863270GENE-TRAK CAMPYLOBACTER ASSAYIntegrated Genetics1987-08-31

Legacy Summary#

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FDA Review#

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