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510(k) K924247

Device
ACCUTEX ASO LATEX TEST
Applicant
J.S. MEDICAL ASSOC.
510(k) number
K924247
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-07
Date received
1992-08-24
Regulation
866.3720
Classification name
Antistreptolysin - Titer/streptolysin O Reagent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD DAVIS
Address
19 Strathmore Rd. Natick MA US 01760 01760

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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