FDA 510(k) Application Details - K961458

Device Classification Name Electrode, Ion Specific, Calcium

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510(K) Number K961458
Device Name Electrode, Ion Specific, Calcium
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 862.1145

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Classification Product Code JFP
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Date Received 04/15/1996
Decision Date 06/12/1996
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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