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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 K803016
Device Name HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
Applicant
Helena Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Helena Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5620
Classification Product Code
GKR  
Date Received11/28/1980
Decision Date 12/30/1980
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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