PMA P230019

Device: MediBeacon® Transdermal GFR Measurement System (TGFR)
Applicant: Medibeacon, Inc.
Product code: SDK
Decision date: 2025-12-15
Generic name: Transdermal test for Assessment of Glomerular Filtration Rate
Approval order statement: for the addition of the MediBeacon Reusable Sensor to the MediBeacon® Transdermal GFR System and the extension of the Lumitrace component shelf life from 1 year to 2 years.

Current openFDA PMA Record

Device: MediBeacon® Transdermal GFR Measurement System (TGFR)
Applicant: Medibeacon, Inc.
PMA number: P230019
Supplement: S001
Product code: SDK
Generic name: Transdermal test for Assessment of Glomerular Filtration Rate
Decision date: 2025-12-15
Decision code: APPR
Date received: 2025-03-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: for the addition of the MediBeacon Reusable Sensor to the MediBeacon® Transdermal GFR System and the extension of the Lumitrace component shelf life from 1 year to 2 years.