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510(k) K854447

Device
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
Applicant
AMERICAN MICRO SCAN
510(k) number
K854447
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-03
Date received
1985-11-05
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
KRISTA UNDERWOOD
Address
855 57th. St. Suite G Sacramento CA US 95819 95819

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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