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510(k) K872697

Device
PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN
Applicant
SITA, INC.
510(k) number
K872697
Product code
GQT  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-18
Date received
1987-07-07
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#

Contact
JANIS F CHARLTON
Address
Regulatory Affairs Dept. 130 So. Main St. Allentown NJ US 08501 08501

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
K780008GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20

Legacy Summary#

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FDA Review#

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