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FDA 510(k) Application Details - K053612
Device Classification Name
Acid Phosphatase, Naphthyl Phosphate
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510(K) Number
K053612
Device Name
Acid Phosphatase, Naphthyl Phosphate
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
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Contact
ERI HIRUMI
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Regulation Number
862.1020
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Classification Product Code
CKB
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More FDA Info for this Product Code
Date Received
12/27/2005
Decision Date
04/26/2006
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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