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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 K850096
Device Name LASER-GLOBIN
Applicant
Hematology Marketing Assoc.
P.O. Box 6756
Concord,  CA  94524
Applicant Contact JAMES LAPICOLA
Correspondent
Hematology Marketing Assoc.
P.O. Box 6756
Concord,  CA  94524
Correspondent Contact JAMES LAPICOLA
Regulation Number864.5620
Classification Product Code
GKR  
Date Received01/11/1985
Decision Date 03/29/1985
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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