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FDA 510(k)

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

K-Number: K220085 · 2023-08-24

ApplicantKronus, Inc.
Decision Date2023-08-24
Product CodeOIF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kronus, Inc.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K220085. The device is classified under product code OIF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Kronus, Inc.. The 510(k) number is K220085.

When did KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit receive FDA 510(k) clearance?

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit received FDA 510(k) clearance on 2023-08-24, under 510(k) number K220085.

Who is the listed applicant for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?

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 IA-2 Autoantibody (IA-2Ab) ELISA Kit?

The FDA product code for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is OIF.

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.

K180607Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitK171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitK161951KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

Related Devices (Code: OIF)

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.

K171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKronus, Inc.

Official Source

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

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