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FDA 510(k) Application Details - K961984
Device Classification Name
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
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510(K) Number
K961984
Device Name
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
Applicant
TRACE AMERICA, INC.
7260 NORTH WEST 58TH ST.
MIAMI, FL 33166 US
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Contact
David Johnston
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Regulation Number
862.1590
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Classification Product Code
JNF
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More FDA Info for this Product Code
Date Received
05/21/1996
Decision Date
12/10/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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