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FDA 510(k) Application Details - K032291
Device Classification Name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
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510(K) Number
K032291
Device Name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Applicant
LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL CH-4051 CH
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JEAN-PIERRE PALMA
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Regulation Number
862.3320
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Classification Product Code
DOA
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Date Received
07/24/2003
Decision Date
08/24/2004
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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