Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators Set

Procalcitonin Assay

Fujirebio Diagnostics, Inc.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G B•r•a•h•m•s Pct Immunoreaction Cartridges, Lumipulse G B•r•a•h•m•s Pct Calibrators Set.

Pre-market Notification Details

• Device ID: K172713
• 510k Number: K172713
• Device Name: Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators Set
• Classification: Procalcitonin Assay
• Applicant: Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
• Contact: Stacey Dolan
• Correspondent: Stacey Dolan; Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
• Product Code: PRI
• Subsequent Product Code: NTM
• Subsequent Product Code: PMT
• CFR Regulation Number: 866.3215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-08
• Decision Date: 2017-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04987270235058	K172713	000
04987270234167	K172713	000
04987270234150	K172713	000
04987270234945	K172713	000
04987270234938	K172713	000