FDA 510(k) Application Details - K993755

Device Classification Name Calibrators, Drug Mixture

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510(K) Number K993755
Device Name Calibrators, Drug Mixture
Applicant SYVA CO.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE, CA 95161-9013 US
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Contact PAUL L ROGERS
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Regulation Number 862.3200

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Classification Product Code DKB
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Date Received 11/05/1999
Decision Date 12/21/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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