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FDA 510(k) Application Details - K971506
Device Classification Name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
More FDA Info for this Device
510(K) Number
K971506
Device Name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
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Contact
SHERI HALL
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Regulation Number
862.3040
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Classification Product Code
DMT
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More FDA Info for this Product Code
Date Received
04/25/1997
Decision Date
06/03/1997
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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