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510(k) K897083

Device
VENTRESIGN STREP A TEST
Applicant
VENTREX LABORATORIES, INC.
510(k) number
K897083
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-22
Date received
1989-12-20
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
JAMES W CHAMPLIN
Address
217 Read St. P.O. Box 9731 Portland ME US 04103 04103

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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