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FDA 510(k) Application Details - K981289
Device Classification Name
Diazo Colorimetry, Bilirubin
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510(K) Number
K981289
Device Name
Diazo Colorimetry, Bilirubin
Applicant
CRESTAT DIAGNOSTICS, INC.
910 INDUSTRY DR.
SEATTLE, WA 98056 US
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COLIN GETTY
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Regulation Number
862.1110
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Classification Product Code
CIG
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More FDA Info for this Product Code
Date Received
04/08/1998
Decision Date
04/27/1998
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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