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510(k) K852841

Device
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
Applicant
SMITH KLINE DIAGNOSTICS, INC.
510(k) number
K852841
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-24
Date received
1985-07-05
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
RONALD J SCHOENGOLD
Address
485 Potrero Ave. P.O. Box 61947 Sunnyvale CA US 94086 94086

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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