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510(k) K872698

Device
ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN
Applicant
SITA, INC.
510(k) number
K872698
Product code
GOA  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-18
Date received
1987-07-07
Regulation
866.3020
Classification name
Antisera, Cf, Adenovirus 1-33
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

Legacy Summary#

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FDA Review#

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