KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay— 510(k) K161951

Name: FDA 510(k) clearance K161951
Creator: U.S. Food and Drug Administration
Published: 2016-07-22

Substantially Equivalent

Kronus, Inc.

FDA 510(k) clearance K161951 for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay, Substantially Equivalent on 2016-07-22. Applicant: Kronus, Inc.. Device class: 2.

Clearance details

Applicant: Kronus, Inc.
Product code: Code PNI
Device class: Class 2
Regulation: 21 CFR 866.5665
Advisory panel: Immunology
Date received: 2016-07-15
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Star, ID, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNI

view all

DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay2016-04-25

More clearances from Kronus, Inc.

view all

K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit2023-08-24
K180607 — Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit2018-11-23
K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit2018-01-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.