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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 K862179
Device Name SOMAS LIQUID URINE CONTROL
Applicant
Somas Medical Industries, Inc.
2740 S. Harbor Blvd.
Suite F
Santa Ana,  CA  92704
Applicant Contact SOM, PH.D.
Correspondent
Somas Medical Industries, Inc.
2740 S. Harbor Blvd.
Suite F
Santa Ana,  CA  92704
Correspondent Contact SOM, PH.D.
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/09/1986
Decision Date 07/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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