FDA 510(k) Application Details - K951434

Device Classification Name Enzyme Immunoassay, Procainamide

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510(K) Number K951434
Device Name Enzyme Immunoassay, Procainamide
Applicant BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD, MA US
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Contact NANCY M JOHANSEN
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Regulation Number 862.3320

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Classification Product Code LAR
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Date Received 03/28/1995
Decision Date 07/03/1995
Decision SE - Substantially Equivalent
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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