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FDA 510(k), K160915, Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
FDA 510(k), K160915, Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
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510(K) Number: K160915
Device Name: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Manufacturer: ROCHE DIAGNOSTICS
Device Classification Name: cytokeratin fragments 21-1 eia kit
Regulation Number: 866.6010
Classification Product Code: OVK
Date Received: 04/01/2016
Decision Date: 12/14/2016
Regulation Medical Specialty: Immunology
Device Name: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Manufacturer: ROCHE DIAGNOSTICS
Device Classification Name: cytokeratin fragments 21-1 eia kit
Regulation Number: 866.6010
Classification Product Code: OVK
Date Received: 04/01/2016
Decision Date: 12/14/2016
Regulation Medical Specialty: Immunology
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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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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