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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K012243
Device Name MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
Applicant
Hematronix, Inc.
524 Stone Rd.
Suite A
Benicia,  CA  94510
Applicant Contact JAMES S AFRANKO
Correspondent
Hematronix, Inc.
524 Stone Rd.
Suite A
Benicia,  CA  94510
Correspondent Contact JAMES S AFRANKO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/17/2001
Decision Date 08/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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