FDA 510(k) Application Details - K030211

Device Classification Name Thin Layer Chromatography, Barbiturate

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510(K) Number K030211
Device Name Thin Layer Chromatography, Barbiturate
Applicant ICN BIOMEDICALS, INC.
1429 ROLLINS RD.
BURLINGAME, CA 94010 US
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Contact CHARKES C.F. YU
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Regulation Number 862.3150

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Classification Product Code DKX
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Date Received 01/21/2003
Decision Date 06/13/2003
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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