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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion-Specific, Chloride
510(k) Number K003664
Device Name DELFIA NEONATAL IRT KIT, MODEL A005-110
Applicant
Wallac OY
Mustionkatu 6
Turku,  FI 20750
Applicant Contact GUNNEL LAAKSONEN
Correspondent
Wallac OY
Mustionkatu 6
Turku,  FI 20750
Correspondent Contact GUNNEL LAAKSONEN
Regulation Number862.1170
Classification Product Code
CGZ  
Date Received11/28/2000
Decision Date 02/14/2001
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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