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510(k) K860923

Device
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
Applicant
SELF CARE SYSTEMS, INC.
510(k) number
K860923
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-16
Date received
1986-03-11
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
CHANDRAVADAN PATEL
Address
1527 Monrovia Ave. Newport Beach CA US 92663 92663

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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