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FDA 510(k) Application Details - K955434
Device Classification Name
Acid, Folic, Radioimmunoassay
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510(K) Number
K955434
Device Name
Acid, Folic, Radioimmunoassay
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA, CA 92822-8000 US
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Contact
KIMNIS WALKER
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Regulation Number
862.1295
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Classification Product Code
CGN
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More FDA Info for this Product Code
Date Received
10/02/1995
Decision Date
01/29/1996
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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