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510(k) K780008

Device
GOAT ANTI-INFLUENZA ANTISERA
Applicant
NORTHEAST BIOMEDICAL LABS., INC.
510(k) number
K780008
Product code
GQT  
Decision
Substantially Equivalent (SESE)
Decision date
1978-01-20
Date received
1978-01-03
Regulation
866.3400
Classification name
Antisera, Cf, Parainfluenza Virus 1-4
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GQT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872695PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18
K872696PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18
K872697PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18

Legacy Summary#

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FDA Review#

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