PMA P230019S003

Device: MediBeacon® Transdermal GFR Measurement System (GFR)
Applicant: Medibeacon, Inc.
PMA number: P230019
Supplement: S003
Product code: SDK
Decision date: 2025-11-20
Classification: Gastroenterology, Urology
Generic name: Transdermal test for Assessment of Glomerular Filtration Rate
Approval order statement: approval for a manufacturing site located at Tjoapack, LLC, 341 JD Yarnell Industrial Parkway, Clinton, TN 37716 for labeling and secondary packaging of device.

Current openFDA PMA Record#

Device: MediBeacon® Transdermal GFR Measurement System (GFR)
Applicant: Medibeacon, Inc.
PMA number: P230019
Supplement: S003
Product code: SDK
Generic name: Transdermal test for Assessment of Glomerular Filtration Rate
Decision date: 2025-11-20
Decision code: APPR
Date received: 2025-09-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Tjoapack, LLC, 341 JD Yarnell Industrial Parkway, Clinton, TN 37716 for labeling and secondary packaging of device.