MediBeacon® Transdermal GFR Measurement System (GFR)
FDA premarket approval P230019/S003 · decided 2025-11-20
Approval details
- PMA number
- P230019
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MediBeacon® Transdermal GFR Measurement System (GFR)
- Generic name
- Transdermal test for Assessment of Glomerular Filtration Rate
- Applicant
- Medibeacon, Inc.
- Date received
- 2025-09-25
- Decision date
- 2025-11-20
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- SDK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Louis, MO
- 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.
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