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FDA 510(k) Application Details - K972382
Device Classification Name
Diazo Colorimetry, Bilirubin
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510(K) Number
K972382
Device Name
Diazo Colorimetry, Bilirubin
Applicant
ARROWS CO., LTD.
2-7-50 NISHIMIYAHARA YODOGA-KU
OSAKA JP
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Contact
YOSHIMASA OGOSHI
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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
06/26/1997
Decision Date
09/14/1998
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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