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FDA 510(k) Application Details - K060280
Device Classification Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
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510(K) Number
K060280
Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant
IRIS INTERNATIONAL, INC.
9172 ETON AVE.
CHATSWORTH, CA 91311 US
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Contact
GERALD J HADDOCK
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Regulation Number
862.1340
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Classification Product Code
JIL
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More FDA Info for this Product Code
Date Received
02/02/2006
Decision Date
06/13/2006
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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