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FDA 510(k)

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

K-Number: K180607 · 2018-11-23

ApplicantKronus, Inc.
Decision Date2018-11-23
Product CodePCG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Steroid 21-Hydroxylase Antibody (21-OHAb) 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 2018-11-23 under 510(k) number K180607. The device is classified under product code PCG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Kronus, Inc.. The 510(k) number is K180607.

When did Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit receive FDA 510(k) clearance?

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit received FDA 510(k) clearance on 2018-11-23, under 510(k) number K180607.

Who is the listed applicant for Steroid 21-Hydroxylase Antibody (21-OHAb) 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 Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

The FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is PCG.

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 KitK171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitK161951KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

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.

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