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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 K891767
Device Name GENETIC SYSTEMS MICROPLATE READER
Applicant
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Applicant Contact MONICA S KRIEGER
Correspondent
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Correspondent Contact MONICA S KRIEGER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/24/1989
Decision Date 07/25/1989
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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