RAPID AS LATEX

Antistreptolysin - Titer/streptolysin O Reagent

DILAB, INC.

The following data is part of a premarket notification filed by Dilab, Inc. with the FDA for Rapid As Latex.

Pre-market Notification Details

Device IDK862530
510k NumberK862530
Device Name:RAPID AS LATEX
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant DILAB, INC. 7003 N.W. 50TH ST. Miami,  FL  33166
ContactRafael A Quevedo
CorrespondentRafael A Quevedo
DILAB, INC. 7003 N.W. 50TH ST. Miami,  FL  33166
Product CodeGTQ  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-02
Decision Date1987-04-21

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