FDA 510(k) Application Details - K062316

Device Classification Name Enzymatic Method, Ammonia

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510(K) Number K062316
Device Name Enzymatic Method, Ammonia
Applicant DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK, DE 19714-6101 US
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Contact LORRAINE H PIESTRAK
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Regulation Number 862.1065

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Classification Product Code JIF
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Date Received 08/09/2006
Decision Date 09/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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