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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 K853920
Device Name BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
Applicant
Bio-Tek Instruments, Inc.
One Mill St.
Burlington,  VT  05401
Applicant Contact DAVID W KLYSZEIKO
Correspondent
Bio-Tek Instruments, Inc.
One Mill St.
Burlington,  VT  05401
Correspondent Contact DAVID W KLYSZEIKO
Regulation Number866.2500
Classification Product Code
JTC  
Date Received09/23/1985
Decision Date 10/22/1985
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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