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510(k) K951542

Device
DIRECTIGEN 1-2-3 GROUP A STREP TEST
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K951542
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-20
Date received
1995-04-03
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JUDITH J SMITH
Address
P.O. Box 987 Columbus NE US 68602 68602

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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