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FDA 510(k), K173327, DIP/U.S. Urine Analysis Test System
FDA 510(k), K173327, DIP/U.S. Urine Analysis Test System
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$149.00 USD
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510(K) Number: K173327
Device Name: DIP/U.S. Urine Analysis Test System
Manufacturer: Ron Zohar
Device Classification Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation Number: JIL
Classification Product Code: 10/20/2017
Date Received: 07/18/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: DIP/U.S. Urine Analysis Test System
Manufacturer: Ron Zohar
Device Classification Name: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation Number: JIL
Classification Product Code: 10/20/2017
Date Received: 07/18/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- 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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