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FDA 510(k) Application Details - K971058
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K971058
Device Name
Drug Mixture Control Materials
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
542 FLYNN RD.
CAMARILLO, CA 93012-8058 US
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SCOT KINGHORN
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Regulation Number
862.3280
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Classification Product Code
DIF
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More FDA Info for this Product Code
Date Received
03/24/1997
Decision Date
04/08/1997
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
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