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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Erythropoietin
510(k) Number K910481
Device Name EPO-RIA
Applicant
Ramco Laboratories, Inc.
4507 Mt.Vernon
Houston,  TX  77006
Applicant Contact CANDICE GORIN
Correspondent
Ramco Laboratories, Inc.
4507 Mt.Vernon
Houston,  TX  77006
Correspondent Contact CANDICE GORIN
Regulation Number864.7250
Classification Product Code
GGT  
Date Received02/06/1991
Decision Date 11/29/1991
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
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