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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K941965
Device Name EZ-RANGE
Applicant
Hematronix, Inc.
524 Stone Rd.
Suite A
Benicia,  CA  94510
Applicant Contact DEBBY BERCE
Correspondent
Hematronix, Inc.
524 Stone Rd.
Suite A
Benicia,  CA  94510
Correspondent Contact DEBBY BERCE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received04/22/1994
Decision Date 04/25/1995
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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