• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K843755, UROPAPER EIKEN 6B, by Syn-Kit, Inc.

FDA 510(k) K843755, UROPAPER EIKEN 6B, by Syn-Kit, Inc.

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510(K) Number: K843755
Device Name: UROPAPER EIKEN 6B
Manufacturer: Syn-Kit, Inc.
Device Classification Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 09/25/1984
Decision Date: 12/18/1984
Regulation Medical Specialty: Clinical Chemistry
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