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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K081719
Device Name STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
Applicant
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Applicant Contact KIRK JOHNSON
Correspondent
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Correspondent Contact KIRK JOHNSON
Regulation Number864.5620
Classification Product Code
GKR  
Date Received06/18/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
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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