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510(k) K791282

Device
ANTI-HUMAN SERUM
Applicant
DIAGNOSTICA, INC.
510(k) number
K791282
Product code
DGQ  
Decision
Substantially Equivalent (SESE)
Decision date
1979-10-17
Date received
1979-07-10
Regulation
866.5700
Classification name
Whole Blood Plasma, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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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