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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K121864
Device Name PERKINELMER 226 SAMPLE COLLECTION DEVICES
Original Applicant
PERKINELMER, INC.
17 p&n drive
greenville,  SC  29611
Original Contact kay a taylor
Regulation Number862.1675
Classification Product Code
JKA  
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
Recalls CDRH Recalls
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