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FDA 510(k)

SAMPLOK

K-Number: K000777 · 2000-04-11

ApplicantItl Corporation Pty, Ltd.
Decision Date2000-04-11
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAMPLOK 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 2000-04-11 under 510(k) number K000777. 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?

SAMPLOK is a medical device that received FDA 510(k) clearance on 2000-04-11. The listed applicant is Itl Corporation Pty, Ltd.. The 510(k) number is K000777.

When did SAMPLOK receive FDA 510(k) clearance?

SAMPLOK received FDA 510(k) clearance on 2000-04-11, under 510(k) number K000777.

Who is the listed applicant for SAMPLOK?

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?

The FDA product code for SAMPLOK is JKA.

Related Clinical Trials

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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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.

K153472Quiver Laparoscopic ExtendableK021941SAMPLOK LUER KITK021017LEESPEC DISPOSABLE VAGINAL SPECULUMK991404PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)

Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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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