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FDA 510(k) Application Details - K964695
Device Classification Name
Albumin, Antigen, Antiserum, Control
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510(K) Number
K964695
Device Name
Albumin, Antigen, Antiserum, Control
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
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Contact
FRANK MARTE
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Regulation Number
866.5040
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Classification Product Code
DCF
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More FDA Info for this Product Code
Date Received
11/22/1996
Decision Date
04/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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