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510(k) K881209

Device
ASO SLIDE TEST
Applicant
NCS DIAGNOSTICS, INC.
510(k) number
K881209
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-12
Date received
1988-03-21
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
ALLEN CHAN
Address
130 Matheson Blvd. E. Mississauga, L4z 1y6 CA

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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