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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 K936258
Device Name SYSTEM WASHER 100
Applicant
Eg&G Berthold
D-75312 Bad Wildbad
Germany,  DE
Applicant Contact LOTHAR NOFER
Correspondent
Eg&G Berthold
D-75312 Bad Wildbad
Germany,  DE
Correspondent Contact LOTHAR NOFER
Regulation Number862.2750
Classification Product Code
JQW  
Date Received12/30/1993
Decision Date 04/26/1994
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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