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FDA 510(k) Application Details - K972363
Device Classification Name
Photometric Method, Iron (Non-Heme)
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510(K) Number
K972363
Device Name
Photometric Method, Iron (Non-Heme)
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON, MA 02173 US
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Contact
BETTY J LANE
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Regulation Number
862.1410
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Classification Product Code
JIY
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More FDA Info for this Product Code
Date Received
06/25/1997
Decision Date
08/15/1997
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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