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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K923456
Device Name MICROLITE MICROTITER PLATE LUMINOMETER ML3000
Applicant
DYNATECH LABORATORIES, INC.
14340 SULLYFIELD CIRCLE
CHANTILLY,  VA  22021
Applicant Contact WATREN D GEHLE
Correspondent
DYNATECH LABORATORIES, INC.
14340 SULLYFIELD CIRCLE
CHANTILLY,  VA  22021
Correspondent Contact WATREN D GEHLE
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/14/1992
Decision Date 10/13/1992
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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