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FDA 510(k)

TrueCare Biomedix Tamper Evident Cap

K-Number: K210818 · 2021-09-15

ApplicantUs Infusion Inc. D/B/A Truecare Biomedix-USA
Decision Date2021-09-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TrueCare Biomedix Tamper Evident Cap is the device name listed in this FDA 510(k) record. The listed applicant is Us Infusion Inc. D/B/A Truecare Biomedix-USA. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K210818. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrueCare Biomedix Tamper Evident Cap?

TrueCare Biomedix Tamper Evident Cap is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Us Infusion Inc. D/B/A Truecare Biomedix-USA. The 510(k) number is K210818.

When did TrueCare Biomedix Tamper Evident Cap receive FDA 510(k) clearance?

TrueCare Biomedix Tamper Evident Cap received FDA 510(k) clearance on 2021-09-15, under 510(k) number K210818.

Who is the listed applicant for TrueCare Biomedix Tamper Evident Cap?

The FDA 510(k) record lists Us Infusion Inc. D/B/A Truecare Biomedix-USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueCare Biomedix Tamper Evident Cap?

The FDA product code for TrueCare Biomedix Tamper Evident Cap is FMF.

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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