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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. Hwy. 202
Somerville,  NJ  08876
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
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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