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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K920888
Device Name MICROLITE MICROTITER PLATE LUMINOMETER ML2200
Applicant
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact WARREN D GEHLE
Correspondent
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact WARREN D GEHLE
Regulation Number862.2560
Classification Product Code
KHO  
Date Received02/11/1992
Decision Date 03/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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