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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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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: KXA
Date Received: 10/20/2017
Decision Date: 07/18/2018
Decision: 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: KXA
Date Received: 10/20/2017
Decision Date: 07/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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