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FDA 510(k) Application Details - K180835
Device Classification Name
Colorimetry, Acetaminophen
More FDA Info for this Device
510(K) Number
K180835
Device Name
Colorimetry, Acetaminophen
Applicant
Sekisui Diagnostics PEI Inc.
70 Watts Avenue
Charlottetown C1E 2B9 CA
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Contact
Penny White
Other 510(k) Applications for this Contact
Regulation Number
862.3030
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Classification Product Code
LDP
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More FDA Info for this Product Code
Date Received
03/30/2018
Decision Date
02/08/2019
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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