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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 K895313
Device Name MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
Applicant
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact BARRY LAZAR
Correspondent
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact BARRY LAZAR
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/29/1989
Decision Date 10/17/1989
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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