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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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