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FDA 510(k)

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

K-Number: K243533 · 2025-01-13

ApplicantHlb Co., Ltd. Healthcare
Decision Date2025-01-13
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is a medical device manufactured by Hlb Co., Ltd. Healthcare. It received FDA 510(k) clearance on 2025-01-13 under approval number K243533. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Hlb Co., Ltd. Healthcare. The 510(k) number is K243533.

When was Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus approved by the FDA?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus received FDA 510(k) clearance on 2025-01-13, under approval number K243533.

What company makes Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is manufactured by Hlb Co., Ltd. Healthcare.

What is the FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

The FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is FMK.

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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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