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FDA 510(k) Application Details - K030835
Device Classification Name
Enzyme Immunoassay, Propoxyphene
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510(K) Number
K030835
Device Name
Enzyme Immunoassay, Propoxyphene
Applicant
AMERICAN BIO MEDICA CORP.
9110 RED BRANCH RD.
COLUMBIA, MD 21045 US
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Contact
HENRY WELLS
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Regulation Number
862.3700
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Classification Product Code
JXN
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More FDA Info for this Product Code
Date Received
03/17/2003
Decision Date
05/22/2003
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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