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FDA Device Info: VIVOSENS BIYOTEKNOLOJI AR-GE Records
FDA Device Info: VIVOSENS BIYOTEKNOLOJI AR-GE Records
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We request all documents related to the placement of VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI and its Vivoo Test Strips on the red list of IA 89-08 on September 30, 2019; including any labels or other documents indicating what caused FDA to consider the device to be a Class II device that requires 510(k) clearance. Please see Vivosens Biyoteknoloji Ar-Ge, San. & Tic. Ltd.
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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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