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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Microtiter Diluting/Dispensing
510(k) Number K873542
Device Name MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
Applicant
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Applicant Contact BOGDAN DZIURZYNSKI
Correspondent
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Correspondent Contact BOGDAN DZIURZYNSKI
Regulation Number866.2500
Classification Product Code
JTC  
Date Received09/01/1987
Decision Date 09/23/1987
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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