FDA 510(k) Application Details - K060355

Device Classification Name Thin Layer Chromatography, Metamphetamine

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510(K) Number K060355
Device Name Thin Layer Chromatography, Metamphetamine
Applicant ACRO BIOTECH LLC.
9500 7TH STREET UNIT M
RANCHO CUCAMONGA, CA 91730-9094 US
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Contact GREGORY LEE
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Regulation Number 862.3610

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Classification Product Code DJC
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Date Received 02/13/2006
Decision Date 08/07/2006
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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