FDA 510(k) Application Details - K121864

Device Classification Name

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510(K) Number K121864
Device Name PERKINELMER 226 SAMPLE COLLECTION DEVICES
Applicant PERKINELMER, INC.
17 P&N DRIVE
GREENVILLE, SC 29611 US
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Contact KAY A TAYLOR
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Regulation Number

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Classification Product Code PJC
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Date Received 06/26/2012
Decision Date 03/12/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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