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FDA 510(k)

INVISIJECT RESUSABLE AUTO-INJECTOR

K-Number: K032425 · 2003-11-05

ApplicantBiogen
Decision Date2003-11-05
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INVISIJECT RESUSABLE AUTO-INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biogen. It received FDA 510(k) clearance on 2003-11-05 under 510(k) number K032425. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVISIJECT RESUSABLE AUTO-INJECTOR?

INVISIJECT RESUSABLE AUTO-INJECTOR is a medical device that received FDA 510(k) clearance on 2003-11-05. The listed applicant is Biogen. The 510(k) number is K032425.

When did INVISIJECT RESUSABLE AUTO-INJECTOR receive FDA 510(k) clearance?

INVISIJECT RESUSABLE AUTO-INJECTOR received FDA 510(k) clearance on 2003-11-05, under 510(k) number K032425.

Who is the listed applicant for INVISIJECT RESUSABLE AUTO-INJECTOR?

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

What is the FDA product code for INVISIJECT RESUSABLE AUTO-INJECTOR?

The FDA product code for INVISIJECT RESUSABLE AUTO-INJECTOR is KZH.

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Other records listing Biogen 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.

K042314SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE

Related Devices (Code: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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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