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510(k) K874761

Device
RAPID COLORIMETRIC DIRECT STREP A TEST
Applicant
NEW HORIZONS DIAGNOSTICS CO.
510(k) number
K874761
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-19
Date received
1987-11-19
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
ANN CARTER
Address
9110 Red Branch Rd. Suite B Columbia MD US 21045 21045

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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