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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Manufacturer

Tianjin Huahong Technology Co., Ltd.

Date Cleared

2025-06-26

(24 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The safety lancet is intended for capillary blood sampling.

Device Description

The safety lancet is single use medical device, which is designed to collect capillary blood sample.

The intended users include Healthcare personnel, patients and lay persons.

Model XXXVI, the safety lancets consist of needle core, button, housing, protective cap and spring.

The sterile part of the safety lancet is the needle tip.

The sterile barrier is the needle sleeve and sterilized to a SAL of 10⁻⁶ by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

AI/ML Overview

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