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FDA 510(k) Application Details - K053566
Device Classification Name
Test,System,Potassium,Enzymatic Method
More FDA Info for this Device
510(K) Number
K053566
Device Name
Test,System,Potassium,Enzymatic Method
Applicant
DIAZYME LABORATORIES
3550 GENERAL ATOMICS CT.
SAN DIEGO, CA 92121 US
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Contact
HUAN TRAN
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Regulation Number
862.1600
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Classification Product Code
MZV
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More FDA Info for this Product Code
Date Received
12/22/2005
Decision Date
02/15/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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