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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 K100682
Device Name GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
Applicant
Wallac OY
8275 Carloway Rd.
Indianapolis,  IN  46236
Applicant Contact KAY TAYLOR
Correspondent
Wallac OY
8275 Carloway Rd.
Indianapolis,  IN  46236
Correspondent Contact KAY TAYLOR
Regulation Number862.1395
Classification Product Code
JLX  
Date Received03/10/2010
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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