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FDA 510(k) Application Details - K974784
Device Classification Name
Electrode, Ion Specific, Potassium
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510(K) Number
K974784
Device Name
Electrode, Ion Specific, Potassium
Applicant
AVL SCIENTIFIC CORP.
33 MANSELL COURT
ROSWELL, GA 30076-4807 US
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Contact
RANDY BYRD
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Regulation Number
862.1600
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Classification Product Code
CEM
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More FDA Info for this Product Code
Date Received
12/22/1997
Decision Date
02/24/1998
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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