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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K862530
Device Name RAPID AS LATEX
Applicant
Dilab, Inc.
7003 NW 50th St.
Miami,  FL  33166
Applicant Contact RAFAEL A QUEVEDO
Correspondent
Dilab, Inc.
7003 NW 50th St.
Miami,  FL  33166
Correspondent Contact RAFAEL A QUEVEDO
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received07/02/1986
Decision Date 04/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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