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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 K031441
Device Name URICHEMTRAK LIQUID ASSAYED URINE CONTROL
Applicant
Medical Analysis Systems, Inc.
5300 Adolfo Rd.
Camarillo,  CA  93012
Applicant Contact PENNY M LAYMAN
Correspondent
Medical Analysis Systems, Inc.
5300 Adolfo Rd.
Camarillo,  CA  93012
Correspondent Contact PENNY M LAYMAN
Regulation Number862.1660
Classification Product Code
JJW  
Date Received05/06/2003
Decision Date 07/01/2003
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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