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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K002354
Device Name CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1160
Classification Product Code
KHS  
Date Received08/02/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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