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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, 17-Hydroxyprogesterone
510(k) Number K050960
Device Name MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
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 Number862.1395
Classification Product Code
JLX  
Date Received04/18/2005
Decision Date 07/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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