Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

K-Number: K161951 · 2016-07-22

ApplicantKronus, Inc.
Decision Date2016-07-22
Product CodePNI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is the device name listed in this FDA 510(k) record. The listed applicant is Kronus, Inc.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161951. The device is classified under product code PNI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay?

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Kronus, Inc.. The 510(k) number is K161951.

When did KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay receive FDA 510(k) clearance?

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161951.

Who is the listed applicant for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay?

The FDA 510(k) record lists Kronus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay?

The FDA product code for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is PNI.

Other records listing Kronus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220085KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitK180607Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitK171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑