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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 K922723
Device Name TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
Applicant
Simplicity Diagnostics, Inc.
P.O. Box 730
21 N. York Rd.
Hatboro,  PA  19040
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Simplicity Diagnostics, Inc.
P.O. Box 730
21 N. York Rd.
Hatboro,  PA  19040
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received06/05/1992
Decision Date 09/18/1992
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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