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FDA 510(k), K151429, QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
FDA 510(k), K151429, QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
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510(K) Number: K151429
Device Name: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
Manufacturer: INOVA DIAGNOSTICS, INC.
Device Classification Name: extractable antinuclear antibody, antigen and control
Regulation Number: 866.5100
Classification Product Code: LLL
Date Received: 05/28/2015
Decision Date: 02/12/2016
Regulation Medical Specialty: Immunology
Device Name: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
Manufacturer: INOVA DIAGNOSTICS, INC.
Device Classification Name: extractable antinuclear antibody, antigen and control
Regulation Number: 866.5100
Classification Product Code: LLL
Date Received: 05/28/2015
Decision Date: 02/12/2016
Regulation Medical Specialty: Immunology
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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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