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FDA 510(k)

LARALAB

K-Number: K242500 · 2025-04-16

ApplicantLaralab GmbH
Decision Date2025-04-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LARALAB is the device name listed in this FDA 510(k) record. The listed applicant is Laralab GmbH. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K242500. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARALAB?

LARALAB is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Laralab GmbH. The 510(k) number is K242500.

When did LARALAB receive FDA 510(k) clearance?

LARALAB received FDA 510(k) clearance on 2025-04-16, under 510(k) number K242500.

Who is the listed applicant for LARALAB?

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

What is the FDA product code for LARALAB?

The FDA product code for LARALAB is QIH.

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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.

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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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