FDA 510(k) Application Details - K974699

Device Classification Name Calibrators, Drug Mixture

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510(K) Number K974699
Device Name Calibrators, Drug Mixture
Applicant CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN, TX 78744-1832 US
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Contact WILLIAM CONE
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Regulation Number 862.3200

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Classification Product Code DKB
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Date Received 12/16/1997
Decision Date 01/22/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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