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FDA 510(k) Application Details - K983127
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K983127
Device Name
Drug Mixture Control Materials
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
LINCOLN TECHNOLOGY PARK
542 FLYNN RD.
CAMARILLO, CA 93012 US
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Contact
MARY THORSNESS
Other 510(k) Applications for this Contact
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
09/08/1998
Decision Date
09/14/1998
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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