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510(k) K954257

Device
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
Applicant
QUIDEL CORP.
510(k) number
K954257
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-20
Date received
1995-07-27
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
Robin Weiner
Address
10165 Mckellar Ct. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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