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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 K843758
FOIA Releasable 510(k) K843758
Device Name UROPAPER EIKEN GK
Applicant
Syn-Kit, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact IWAO MATSUOKA
Correspondent
Syn-Kit, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
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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