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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 K060452
Device Name ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
Applicant
Neo-Genesis
4814 NE 107th Ave.
Portland,  OR  97220
Applicant Contact JANNET BALDWIN
Correspondent
Neo-Genesis
4814 NE 107th Ave.
Portland,  OR  97220
Correspondent Contact JANNET BALDWIN
Regulation Number862.1395
Classification Product Code
JLX  
Date Received02/21/2006
Decision Date 03/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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