510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K172713Substantially Equivalent

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

Fujirebio Diagnostics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172713 is the FDA 510(k) clearance record for Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code PRI (Procalcitonin Assay). FDA's definition for product code PRI reads: "To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as...". FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show no recalls naming K172713.

Clearance record

Decision date
Received
(93 days to decision)
Product code
PRI Procalcitonin Assay
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRI

Trailing 12 months

FDA records hold no clearances under product code PRI in the trailing twelve months.

FDA records show no clearances under product code PRI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PRI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260