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FDA 510(k) Application Details - K964565
Device Classification Name
Enzymatic Method, Ammonia
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510(K) Number
K964565
Device Name
Enzymatic Method, Ammonia
Applicant
DADE INTL., INC.
9750 N.W. 25TH ST.
MIAMI, FL 33172 US
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Contact
MARIAN HARDING COCHRAN, EQS.
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Regulation Number
862.1065
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Classification Product Code
JIF
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More FDA Info for this Product Code
Date Received
11/14/1996
Decision Date
11/22/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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