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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 K961674
Device Name ROCHE UNIMATE FRUCTOSAMINE REAGENT
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE,  NJ  08876 -3771
Applicant Contact MARIA FEIJOO
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE,  NJ  08876 -3771
Correspondent Contact MARIA FEIJOO
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/01/1996
Decision Date 09/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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