DeviceClearance

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators— 510(k) K153361

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K153361 for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators, Substantially Equivalent on 2016-04-15. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant
Fujirebio Diagnostics,Inc.
Product code
Code MRG
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malvern, PA, US
Download summary PDFView on FDA.gov ↗

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