FDA 510(k) Application Details - K980521

Device Classification Name Enzyme Immunoassay, Digoxin

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510(K) Number K980521
Device Name Enzyme Immunoassay, Digoxin
Applicant BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact GABRIEL J MURACA, JR.
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Regulation Number 862.3320

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Classification Product Code KXT
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Date Received 01/28/1998
Decision Date 04/02/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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