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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Ha, Treponema Pallidum
510(k) Number K911640
Device Name OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
Applicant
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact LAURA STORMS-TYLER
Regulation Number866.3830
Classification Product Code
GMT  
Date Received04/08/1991
Decision Date 07/24/1991
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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