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FDA 510(k)

Disposable Blood Lancet

K-Number: K221507 · 2022-08-31

Decision Date2022-08-31
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Blood Lancet is the device name listed in this FDA 510(k) record. The listed applicant is SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221507. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Blood Lancet?

Disposable Blood Lancet is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221507.

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

Disposable Blood Lancet received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221507.

Who is the listed applicant for Disposable Blood Lancet?

The FDA 510(k) record lists SteriLance Medical (Suzhou), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Blood Lancet?

The FDA product code for Disposable Blood Lancet is QRK.

Other records listing SteriLance Medical (Suzhou), Inc. 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.

View all 10 devices →

Related Devices (Code: QRK)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.