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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colorimetry, acetaminophen
510(k) Number K042330
Device Name ACETAMINOPHEN-SL ASSAY
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, PRINCE EDWARD,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, PRINCE EDWARD,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.3030
Classification Product Code
LDP  
Date Received08/27/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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