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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 K800642
Device Name RAPI/TEX ASO STANDARD SERUM
Applicant
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received03/24/1980
Decision Date 04/24/1980
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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