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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K051321
Device Name INVIEW
Applicant
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085 -4022
Applicant Contact Erika B Ammirati
Correspondent
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085 -4022
Correspondent Contact Erika B Ammirati
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/20/2005
Decision Date 06/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
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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