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FDA 510(k) Application Details - K994138
Device Classification Name
Enzyme Immunoassay, Cannabinoids
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510(K) Number
K994138
Device Name
Enzyme Immunoassay, Cannabinoids
Applicant
WORLDWIDE MEDICAL CORP.
1900 K STREET, N.W.
WASHINGTON, DC 20006-1108 US
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Contact
LARRY R PILOT
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Regulation Number
862.3870
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Classification Product Code
LDJ
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Date Received
12/07/1999
Decision Date
06/23/2000
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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