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FDA 510(k) Application Details - K973069
Device Classification Name
Enzyme Immunoassay, Methadone
More FDA Info for this Device
510(K) Number
K973069
Device Name
Enzyme Immunoassay, Methadone
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
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Contact
LUCINDA STOCKERT
Other 510(k) Applications for this Contact
Regulation Number
862.3620
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Classification Product Code
DJR
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More FDA Info for this Product Code
Date Received
08/18/1997
Decision Date
09/22/1997
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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