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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 K981059
Device Name ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
Applicant
Diagnostic Chemicals , Ltd.
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Applicant Contact KAREN CALLBECK, R.T.B.SC
Correspondent
Diagnostic Chemicals , Ltd.
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Correspondent Contact KAREN CALLBECK, R.T.B.SC
Regulation Number862.3030
Classification Product Code
LDP  
Date Received03/23/1998
Decision Date 05/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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