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FDA 510(k) Application Details - K980031
Device Classification Name
Colorimetry, Acetaminophen
More FDA Info for this Device
510(K) Number
K980031
Device Name
Colorimetry, Acetaminophen
Applicant
DIAGNOSTIC CHEMICALS LTD.
WEST ROYALTY INDUSTRIAL PARK,
CHARLOTTETOWN, P.E.I. C1E 2A6 CA
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Contact
KAREN CALLBECK
Other 510(k) Applications for this Contact
Regulation Number
862.3030
More FDA Info for this Regulation Number
Classification Product Code
LDP
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More FDA Info for this Product Code
Date Received
01/05/1998
Decision Date
03/03/1998
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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