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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K042243
Device Name MICROALBUMIN MULTI-CALIBRATOR SET
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 Number862.1150
Classification Product Code
JIX  
Date Received08/19/2004
Decision Date 10/04/2004
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
Recalls CDRH Recalls
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