FDA 510(k) Application Details - K994404

Device Classification Name Liquid Chromatography, Morphine

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510(K) Number K994404
Device Name Liquid Chromatography, Morphine
Applicant ALFA SCIENTIFIC DESIGNS, INC.
11494 SORRENTO VALLEY RD.,
SUITE F/M
SAN DIEGO, CA 92121 US
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Contact NAISHU WANG
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Regulation Number 862.3640

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Classification Product Code DPK
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Date Received 12/28/1999
Decision Date 07/05/2000
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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