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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K090846
Device Name GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
Applicant
Perkinelmer, Inc.
8275 Carloway Rd.
Indianapolis,  IN  46236
Applicant Contact KAY A TAYLOR
Correspondent
Perkinelmer, Inc.
8275 Carloway Rd.
Indianapolis,  IN  46236
Correspondent Contact KAY A TAYLOR
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
KHO  
Date Received03/30/2009
Decision Date 09/03/2009
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
Recalls CDRH Recalls
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