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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 K863566
Device Name GSC 1000
Applicant
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Applicant Contact BOGDAN DZIURZYNSKI
Correspondent
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Correspondent Contact BOGDAN DZIURZYNSKI
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/12/1986
Decision Date 10/16/1986
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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