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FDA 510(k) Application Details - K021887
Device Classification Name
Enzyme Immunoassay, Cannabinoids
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510(K) Number
K021887
Device Name
Enzyme Immunoassay, Cannabinoids
Applicant
Lin-Zhi International, Inc.
2391 ZANKER RD., SUITE 340
SAN JOSE, CA 95131-1124 US
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Contact
CHIU CHIN CHANG
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Regulation Number
862.3870
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Classification Product Code
LDJ
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More FDA Info for this Product Code
Date Received
06/07/2002
Decision Date
08/15/2002
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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