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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 K843753
FOIA Releasable 510(k) K843753
Device Name UROPAPER EIKEN GP
Applicant
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact IWAO MATSUOKA
Correspondent
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
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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