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FDA 510(k) K811817, UROPAPER EIKEN AG, by Syn-Kit, Inc.

FDA 510(k) K811817, UROPAPER EIKEN AG, by Syn-Kit, Inc.

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510(K) Number: K811817
Device Name: UROPAPER EIKEN AG
Manufacturer: Syn-Kit, Inc.
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 06/26/1981
Decision Date: 07/15/1981
Regulation Medical Specialty: Clinical Chemistry
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