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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Newborn Screening Specimen Collection Paper
510(k) Number K121864
Device Name PERKINELMER 226 SAMPLE COLLECTION DEVICES
Applicant
Perkinelmer, Inc.
17 P&N Dr.
Greenville,  SC  29611
Applicant Contact KAY A TAYLOR
Correspondent
Perkinelmer, Inc.
17 P&N Dr.
Greenville,  SC  29611
Correspondent Contact KAY A TAYLOR
Regulation Number862.1675
Classification Product Code
PJC  
Date Received06/26/2012
Decision Date 03/12/2013
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
Recalls CDRH Recalls
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