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FDA 510(k)

SEROJET

K-Number: K003908 · 2001-03-08

ApplicantBioject, Inc.
Decision Date2001-03-08
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEROJET is the device name listed in this FDA 510(k) record. The listed applicant is Bioject, Inc.. It received FDA 510(k) clearance on 2001-03-08 under 510(k) number K003908. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEROJET?

SEROJET is a medical device that received FDA 510(k) clearance on 2001-03-08. The listed applicant is Bioject, Inc.. The 510(k) number is K003908.

When did SEROJET receive FDA 510(k) clearance?

SEROJET received FDA 510(k) clearance on 2001-03-08, under 510(k) number K003908.

Who is the listed applicant for SEROJET?

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 SEROJET?

The FDA product code for SEROJET is KZE.

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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 CONNECTORK994384CLICKERK960373BIOJECTOR 2000 MODEL 1B02000K963012BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

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Related Devices (Code: KZE)

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.

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.

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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