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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
510(k) Number K100101
Device Name GSP NEONATALGALT KIT, MODEL 3303-001U
Applicant
Perkinelmer, Inc.
8275 Carloway Rd.
Indianapolis,  IN  46236
Applicant Contact KAY TAYLOR
Correspondent
Perkinelmer, Inc.
8275 Carloway Rd.
Indianapolis,  IN  46236
Correspondent Contact KAY TAYLOR
Regulation Number862.1315
Classification Product Code
KQP  
Date Received01/13/2010
Decision Date 06/11/2010
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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