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FDA 510(k) Application Details - K061419
Device Classification Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
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510(K) Number
K061419
Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM, CA 92807 US
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Contact
JIAN VAECHES
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Regulation Number
862.1645
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Classification Product Code
JIR
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More FDA Info for this Product Code
Date Received
05/22/2006
Decision Date
01/26/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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