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FDA 510(k) Application Details - K980331
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K980331
Device Name
Drug Mixture Control Materials
Applicant
MORE DIAGNOSTICS
2020 11TH ST.
LOS OSOS, CA 93402 US
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Contact
JAMES W SNIPES
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
01/28/1998
Decision Date
03/16/1998
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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