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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 a medical device manufactured by Ltbio Co., Ltd.. It received FDA 510(k) clearance on 2022-08-29 under approval 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. It is manufactured by Ltbio Co., Ltd.. The 510(k) number is K221189.

When was OLIZ LTB-1000A approved by the FDA?

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

What company makes OLIZ LTB-1000A?

OLIZ LTB-1000A is manufactured by Ltbio Co., Ltd..

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

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

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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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