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FDA 510(k) Application Details - K936135
Device Classification Name
Radioimmunoassay, Cannabinoid(S)
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510(K) Number
K936135
Device Name
Radioimmunoassay, Cannabinoid(S)
Applicant
SUDORMED, INC.
12341 NEWPORT AVE., #D-200
SANTA ANA, CA 92705 US
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Contact
JON BOOHER, PH.D.
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Regulation Number
862.3870
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Classification Product Code
LAT
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More FDA Info for this Product Code
Date Received
12/28/1993
Decision Date
06/10/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K936135
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