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510(k) K853073

Device
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
Applicant
MARION LABORATORIES, INC.
510(k) number
K853073
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-01
Date received
1985-07-23
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
WILLIAM H GUINTY
Address
P.O. Box 9627 Kansas City MI US 64134 64134

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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