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FDA 510(k) Application Details - K983703
Device Classification Name
Enzyme Immunoassay, Methadone
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510(K) Number
K983703
Device Name
Enzyme Immunoassay, Methadone
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE, NJ 08876-3771 US
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Contact
RITA SMITH
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Regulation Number
862.3620
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Classification Product Code
DJR
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More FDA Info for this Product Code
Date Received
10/21/1998
Decision Date
12/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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