1
/
of
0
510(k) Premarket Notification – ProNephro AKI™ (K232761)
510(k) Premarket Notification – ProNephro AKI™ (K232761)
Regular price
$69.00 USD
Regular price
Sale price
$69.00 USD
Unit price
/
per
510(K) Number: K232761
Device Name: ProNephro AKI™ (NGAL)
Manufacturer: BioPorto Diagnostic Inc.
Device Classification Name: Acute Kidney Injury Test System
Regulation Number: 862.1220
Classification Product Code: PIG
Date Received: 09/08/2023
Decision Date: 12/07/2023
Regulation Medical Specialty: Clinical Chemistry
Request Contents: 510(k) Premarket Notification Submission Document for acute kidney injury test system, 510(k) Number K232761, Device Name: ProNephro AKI™ (NGAL).
Device Name: ProNephro AKI™ (NGAL)
Manufacturer: BioPorto Diagnostic Inc.
Device Classification Name: Acute Kidney Injury Test System
Regulation Number: 862.1220
Classification Product Code: PIG
Date Received: 09/08/2023
Decision Date: 12/07/2023
Regulation Medical Specialty: Clinical Chemistry
Request Contents: 510(k) Premarket Notification Submission Document for acute kidney injury test system, 510(k) Number K232761, Device Name: ProNephro AKI™ (NGAL).
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details