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FDA 510(k)

Disposable Sterile Lancet

K-Number: K222246 · 2022-11-21

Decision Date2022-11-21
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Sterile Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Rilifine Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222246. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Sterile Lancet?

Disposable Sterile Lancet is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Tianjin Rilifine Medical Device Co., Ltd.. The 510(k) number is K222246.

When did Disposable Sterile Lancet receive FDA 510(k) clearance?

Disposable Sterile Lancet received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222246.

Who is the listed applicant for Disposable Sterile Lancet?

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

What is the FDA product code for Disposable Sterile Lancet?

The FDA product code for Disposable Sterile Lancet is QRL.

Other records listing Tianjin Rilifine Medical Device Co., Ltd. as applicant

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.

Related Devices (Code: QRL)

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.

Official Source

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