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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
Applicant
PERKINELMER, INC.
17 p&n drive
greenville,  SC  29611
Contact kay a taylor
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/26/2012
Decision Date 03/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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