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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cystatin C
510(k) Number K041627
Device Name CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
Applicant
Dako A/S
42 Produktionsvej
Glostrup,  DK dk-2600
Applicant Contact DANA OLSEN
Correspondent
Dako A/S
42 Produktionsvej
Glostrup,  DK dk-2600
Correspondent Contact DANA OLSEN
Regulation Number862.1225
Classification Product Code
NDY  
Subsequent Product Codes
JIT   JJX  
Date Received06/16/2004
Decision Date 09/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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