FDA 510(k), K843757, UROPAPER EIKEN AG
FDA 510(k), K843757, UROPAPER EIKEN AG
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510(K) Number: K843757
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: 09/25/1984
Decision Date: 12/18/1984
Regulation Medical Specialty: Clinical Chemistry
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: 09/25/1984
Decision Date: 12/18/1984
Regulation Medical Specialty: Clinical Chemistry
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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