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FDA 510(k)

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

K-Number: K963012 · 1996-10-15

ApplicantBioject, Inc.
Decision Date1996-10-15
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) is the device name listed in this FDA 510(k) record. The listed applicant is Bioject, Inc.. It received FDA 510(k) clearance on 1996-10-15 under 510(k) number K963012. 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 BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)?

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) is a medical device that received FDA 510(k) clearance on 1996-10-15. The listed applicant is Bioject, Inc.. The 510(k) number is K963012.

When did BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) receive FDA 510(k) clearance?

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) received FDA 510(k) clearance on 1996-10-15, under 510(k) number K963012.

Who is the listed applicant for BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)?

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 BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)?

The FDA product code for BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) 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.CLICKK010623RECONSTITUTION KIT & VIAL CONNECTORK003908SEROJETK994384CLICKERK960373BIOJECTOR 2000 MODEL 1B02000

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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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