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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K843760
Device Name UROPAPER EIKEN G
Applicant
Syn-Kit, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact IWAO MATSUOKA
Correspondent
Syn-Kit, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact IWAO MATSUOKA
Regulation Number862.1340
Classification Product Code
JIL  
Date Received09/25/1984
Decision Date 12/18/1984
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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