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FDA 510(k) Application Details - K965240
Device Classification Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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510(K) Number
K965240
Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
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SHERI HALL
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Regulation Number
862.2160
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Classification Product Code
JJE
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More FDA Info for this Product Code
Date Received
12/30/1996
Decision Date
03/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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