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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K861580
Device Name PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
Applicant
Cetus Corp.
1400 Fifty-Third St.
Emeryville,  CA  94608
Applicant Contact WANDA DEVLAMINCK
Correspondent
Cetus Corp.
1400 Fifty-Third St.
Emeryville,  CA  94608
Correspondent Contact WANDA DEVLAMINCK
Regulation Number862.2750
Classification Product Code
JQW  
Date Received04/28/1986
Decision Date 06/27/1986
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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