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FDA 510(k), K153361, Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
FDA 510(k), K153361, Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
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$149.00 USD
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510(K) Number: K153361
Device Name: Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
Manufacturer: FUJIREBIO DIAGNOSTICS, INC.
Device Classification Name: system, test, vitamin d
Regulation Number: 862.1825
Classification Product Code: MRG
Date Received: 11/20/2015
Decision Date: 04/15/2016
Regulation Medical Specialty: Clinical Chemistry
Device Name: Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
Manufacturer: FUJIREBIO DIAGNOSTICS, INC.
Device Classification Name: system, test, vitamin d
Regulation Number: 862.1825
Classification Product Code: MRG
Date Received: 11/20/2015
Decision Date: 04/15/2016
Regulation Medical Specialty: Clinical Chemistry
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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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