FDA 510(k) Application Details - K062191

Device Classification Name Drug Mixture Control Materials

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510(K) Number K062191
Device Name Drug Mixture Control Materials
Applicant DADE BEHRING, INC.
500 GBC DR., M/S 514
P.O. BOX 6101
NEWARK, DE 19714 US
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Contact VICTOR M CARRIO
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Regulation Number 862.3280

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Classification Product Code DIF
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Date Received 07/31/2006
Decision Date 08/21/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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