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510(k) K854978

Device
DIFCO STREP A LATEX TEST
Applicant
DIFCO LABORATORIES, INC.
510(k) number
K854978
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-18
Date received
1985-12-12
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT
Address
P. O. Box 331058 Detroit MI US 48232 48232

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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