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FDA 510(k) Application Details - K012483
Device Classification Name
Enzyme Immunoassay, Opiates
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510(K) Number
K012483
Device Name
Enzyme Immunoassay, Opiates
Applicant
AMEDITECH, INC.
10340 CAMINO SANTA FE
SUITES F-G
SAN DIEGO, CA 92121 US
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Contact
JOHN WU
Other 510(k) Applications for this Contact
Regulation Number
862.3650
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Classification Product Code
DJG
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More FDA Info for this Product Code
Date Received
08/02/2001
Decision Date
11/30/2001
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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