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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 K993496
Device Name RETIC-QUINOX
Applicant
Hematronix, Inc.
524 Stone Rd.
Suite A
Benicia,  CA  94510
Applicant Contact JAMES D LAPICOLA
Correspondent
Hematronix, Inc.
524 Stone Rd.
Suite A
Benicia,  CA  94510
Correspondent Contact JAMES D LAPICOLA
Regulation Number864.8625
Classification Product Code
JPK  
Date Received10/15/1999
Decision Date 11/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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