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510(k) K880665

Device
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
Applicant
ALLELIX DIAGNOSTICS, INC.
510(k) number
K880665
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-01
Date received
1988-02-18
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
JANET SHAW
Address
6850 Goreway Dr. Mississauga, Ontario Canada L4v 1p1 CA

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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