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510(k) K901371

Device
ASO-CUBE(TM)
Applicant
DIFCO LABORATORIES, INC.
510(k) number
K901371
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-05-15
Date received
1990-03-23
Regulation
866.3720
Classification name
Antistreptolysin - Titer/streptolysin O Reagent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WALTER S FISHER
Address
P. O. Box 331058 Detroit MI US 48232 48232

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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