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FDA 510(k)

RECONSTITUTION KIT & VIAL CONNECTOR

K-Number: K010623 · 2001-04-05

ApplicantBioject, Inc.
Decision Date2001-04-05
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RECONSTITUTION KIT & VIAL CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Bioject, Inc.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010623. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECONSTITUTION KIT & VIAL CONNECTOR?

RECONSTITUTION KIT & VIAL CONNECTOR is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Bioject, Inc.. The 510(k) number is K010623.

When did RECONSTITUTION KIT & VIAL CONNECTOR receive FDA 510(k) clearance?

RECONSTITUTION KIT & VIAL CONNECTOR received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010623.

Who is the listed applicant for RECONSTITUTION KIT & VIAL CONNECTOR?

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

What is the FDA product code for RECONSTITUTION KIT & VIAL CONNECTOR?

The FDA product code for RECONSTITUTION KIT & VIAL CONNECTOR is LHI.

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Other records listing Bioject, 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.

K090003ZETAJETK050734COOL.CLICKK003908SEROJETK994384CLICKERK960373BIOJECTOR 2000 MODEL 1B02000K963012BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

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Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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.

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