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510(k) K862530

Device
RAPID AS LATEX
Applicant
DILAB, INC.
510(k) number
K862530
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-21
Date received
1986-07-02
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
RAFAEL A QUEVEDO
Address
7003 NW 50th St. Miami FL US 33166 33166

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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