ProNephro AKI (NGAL)— 510(k) K232761

Substantially Equivalent

Bioporto Diagnostic, Inc.

FDA 510(k) clearance K232761 for ProNephro AKI (NGAL), Substantially Equivalent on 2023-12-07. Applicant: Bioporto Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Bioporto Diagnostic, Inc.
Product code: Code PIG
Device class: Class 2
Regulation: 21 CFR 862.1220
Advisory panel: Clinical Chemistry
Date received: 2023-09-08
Decision date: 2023-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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