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FDA 510(k)

JLK-ICH

K-Number: K243363 · 2025-01-03

ApplicantJLK, Inc.
Decision Date2025-01-03
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JLK-ICH is the device name listed in this FDA 510(k) record. The listed applicant is JLK, Inc.. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K243363. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JLK-ICH?

JLK-ICH is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is JLK, Inc.. The 510(k) number is K243363.

When did JLK-ICH receive FDA 510(k) clearance?

JLK-ICH received FDA 510(k) clearance on 2025-01-03, under 510(k) number K243363.

Who is the listed applicant for JLK-ICH?

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

What is the FDA product code for JLK-ICH?

The FDA product code for JLK-ICH is QAS.

Other records listing JLK, 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.

View all 8 devices →

Related Devices (Code: QAS)

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.

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.