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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K972710
Device Name QUANTIFY(901)
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 Number862.1660
Classification Product Code
JJW  
Date Received07/21/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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