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FDA 510(k) Application Details - K000462
Device Classification Name
Enzyme Immunoassay, Phencyclidine
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510(K) Number
K000462
Device Name
Enzyme Immunoassay, Phencyclidine
Applicant
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK, DE 19714 US
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Contact
JUDY MCINNIS-BERGER
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Regulation Number
862.3100
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Classification Product Code
LCM
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More FDA Info for this Product Code
Date Received
02/11/2000
Decision Date
04/06/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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