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FDA 510(k)

SAMPLOK LUER KIT

K-Number: K021941 · 2002-07-02

ApplicantItl Corporation Pty, Ltd.
Decision Date2002-07-02
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAMPLOK LUER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Itl Corporation Pty, Ltd.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021941. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMPLOK LUER KIT?

SAMPLOK LUER KIT is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Itl Corporation Pty, Ltd.. The 510(k) number is K021941.

When did SAMPLOK LUER KIT receive FDA 510(k) clearance?

SAMPLOK LUER KIT received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021941.

Who is the listed applicant for SAMPLOK LUER KIT?

The FDA 510(k) record lists Itl Corporation Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAMPLOK LUER KIT?

The FDA product code for SAMPLOK LUER KIT is JKA.

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Other records listing Itl Corporation Pty, 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.

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Related Devices (Code: JKA)

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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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