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FDA 510(k)

OLIZ LTB-1000A

K-Number: K221189 · 2022-08-29

ApplicantLtbio Co., Ltd.
Decision Date2022-08-29
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OLIZ LTB-1000A is the device name listed in this FDA 510(k) record. The listed applicant is Ltbio Co., Ltd.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221189. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLIZ LTB-1000A?

OLIZ LTB-1000A is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Ltbio Co., Ltd.. The 510(k) number is K221189.

When did OLIZ LTB-1000A receive FDA 510(k) clearance?

OLIZ LTB-1000A received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221189.

Who is the listed applicant for OLIZ LTB-1000A?

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

What is the FDA product code for OLIZ LTB-1000A?

The FDA product code for OLIZ LTB-1000A is ILY.

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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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