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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K060140
Device Name CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Applicant Contact PENNY WHITE
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Correspondent Contact PENNY WHITE
Regulation Number862.1150
Classification Product Code
JIT  
Date Received01/19/2006
Decision Date 04/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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