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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 K003120
Device Name MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
Applicant
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Applicant Contact KAY A TAYLOR
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Correspondent Contact KAY A TAYLOR
Regulation Number864.7470
Classification Product Code
LCP  
Date Received10/05/2000
Decision Date 12/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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