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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 K874598
Device Name DYNATECH MR 250 MANUAL MICROELISA READER
Applicant
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact DOUGLAS POLLAK
Correspondent
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact DOUGLAS POLLAK
Regulation Number866.2500
Classification Product Code
JTC  
Date Received11/09/1987
Decision Date 11/20/1987
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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