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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K935047
Device Name AUTO DELFIA
Applicant
Wallac OY
P.O. Box 10
Sf-20101 Turku
Finland,  FI
Applicant Contact GUNNELL LAAKSONEN
Correspondent
Wallac OY
P.O. Box 10
Sf-20101 Turku
Finland,  FI
Correspondent Contact GUNNELL LAAKSONEN
Regulation Number862.2560
Classification Product Code
KHO  
Date Received10/21/1993
Decision Date 05/23/1994
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
Recalls CDRH Recalls
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