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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 K912373
Device Name KETO-340 II
Applicant
Ihara Medics U.S., Inc.
25030 Ave. Tibbits, Unit K
Valencia,  CA  91355
Applicant Contact LEONARD SPOLTER
Correspondent
Ihara Medics U.S., Inc.
25030 Ave. Tibbits, Unit K
Valencia,  CA  91355
Correspondent Contact LEONARD SPOLTER
Regulation Number862.1435
Classification Product Code
JIN  
Date Received05/29/1991
Decision Date 07/01/1991
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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