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510(k) K952873

Device
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
Applicant
MEDIX BIOTECH, INC.
510(k) number
K952873
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-08
Date received
1995-06-06
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
DELIA R BETHELL
Address
1531 Industrial Rd. San Carlos CA US 94070 94070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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