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FDA 510(k) Application Details - K022072
Device Classification Name
Bromcresol Green Dye-Binding, Albumin
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510(K) Number
K022072
Device Name
Bromcresol Green Dye-Binding, Albumin
Applicant
PRECISION SYSTEMS, INC.
16 TECH CIRCLE
NATICK, MA 01760 US
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Contact
BILL HADEN
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Regulation Number
862.1035
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Classification Product Code
CIX
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More FDA Info for this Product Code
Date Received
06/26/2002
Decision Date
08/23/2002
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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