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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyclosporine
510(k) Number K080751
Device Name ARCHITECT CYCLOSPORINE
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355 -1307
Applicant Contact STACEY MOLL
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355 -1307
Correspondent Contact STACEY MOLL
Regulation Number862.1235
Classification Product Code
MKW  
Subsequent Product Code
DLJ  
Date Received03/18/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
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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