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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 K081875
Device Name GENTIAN CYSTATIN C IMMUNOASSAY
Applicant
Gentian AS
9915 Cam, Chirimolla
San Diego,  CA  92131
Applicant Contact ERIC S GRUFF
Correspondent
Gentian AS
9915 Cam, Chirimolla
San Diego,  CA  92131
Correspondent Contact ERIC S GRUFF
Regulation Number862.1225
Classification Product Code
NDY  
Date Received07/02/2008
Decision Date 08/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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