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510(k) K903854

Device
RAPITEX(R) ASL NEW
Applicant
BEHRING DIAGNOSTICS, INC.
510(k) number
K903854
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-28
Date received
1990-08-21
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
JOHN E HUGHES
Address
17 Chubb Way Somerville NJ US 08876 08876

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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