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FDA 510(k) Application Details - K051526
Device Classification Name
Automated Urinalysis System
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510(K) Number
K051526
Device Name
Automated Urinalysis System
Applicant
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM, CA 92807 US
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Contact
STEPHANIE LOW
Other 510(k) Applications for this Contact
Regulation Number
862.2900
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Classification Product Code
KQO
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More FDA Info for this Product Code
Date Received
06/08/2005
Decision Date
08/16/2005
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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