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FDA 510(k) Application Details - K973074
Device Classification Name
Chromatography (Liquid, Gel), Clinical Use
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510(K) Number
K973074
Device Name
Chromatography (Liquid, Gel), Clinical Use
Applicant
WATERS CORPORATION
34 MAPLE ST.
MILFORD, MA 01757-3696 US
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VIRGINIA L CORBIN
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Regulation Number
862.2260
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Classification Product Code
KZR
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More FDA Info for this Product Code
Date Received
08/18/1997
Decision Date
10/06/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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