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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K903365
Device Name KETOREX SANWA STANDARDS
Applicant
Ihara Medics U.S., Inc.
25030 Ave. Tibbits, Unit K
Valencia,  CA  91355
Applicant Contact SPOLTER, PHD
Correspondent
Ihara Medics U.S., Inc.
25030 Ave. Tibbits, Unit K
Valencia,  CA  91355
Correspondent Contact SPOLTER, PHD
Regulation Number862.1435
Classification Product Code
JIN  
Date Received07/26/1990
Decision Date 12/20/1990
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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