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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Serological, Positive Control
510(k) Number K970100
Device Name TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
Applicant
Simplicity Diagnostics, Inc.
31 N. York Rd.
Hatboro,  PA  19040
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Simplicity Diagnostics, Inc.
31 N. York Rd.
Hatboro,  PA  19040
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number862.1660
Classification Product Code
MJX  
Date Received01/10/1997
Decision Date 03/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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