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FDA 510(k) Application Details - K023316
Device Classification Name
Calibrators, Drug Specific
More FDA Info for this Device
510(K) Number
K023316
Device Name
Calibrators, Drug Specific
Applicant
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SYNNYVALE, CA 94085-2917 US
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Contact
CHIU CHIN CHANG
Other 510(k) Applications for this Contact
Regulation Number
862.3200
More FDA Info for this Regulation Number
Classification Product Code
DLJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2002
Decision Date
12/16/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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