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510(k) K933575

Device
VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT
Applicant
SYMEX CORP.
510(k) number
K933575
Product code
GQP  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-28
Date received
1993-07-23
Regulation
866.3400
Classification name
Antisera, Neutralization, Parainfluenza Virus 1-4
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CRAIG D SHIMASAKI
Address
P.O. Box 690355 Tulsa OK US 74169 74169

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981226IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3Dako Diagnostics , Ltd.1998-09-28

Legacy Summary#

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FDA Review#

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