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FDA 510(k) Application Details - K014167
Device Classification Name
System, Test, Blood Glucose, Over The Counter
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510(K) Number
K014167
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
POLYMEDICA PHARMACEUTICALS, U.S.A., INC.]
11 STATE ST.
WOBURN, MA 01801 US
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Contact
PATRICIA COLLINS
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
12/19/2001
Decision Date
02/19/2002
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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