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FDA 510(k), K183432, cobas u 601 urinalysis test system
FDA 510(k), K183432, cobas u 601 urinalysis test system
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510(K) Number: K183432
Device Name: cobas u 601 urinalysis test system
Manufacturer: Roche Diagnostics
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 12/11/2018
Decision Date: 05/07/2019
Regulation Medical Specialty: Clinical Chemistry
Device Name: cobas u 601 urinalysis test system
Manufacturer: Roche Diagnostics
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 12/11/2018
Decision Date: 05/07/2019
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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