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FDA 510(k)

RUBAGEN

K-Number: K893755 · 1989-08-21

ApplicantBiokit USA, Inc.
Decision Date1989-08-21
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBAGEN is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K893755. The device is classified under product code LQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBAGEN?

RUBAGEN is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Biokit USA, Inc.. The 510(k) number is K893755.

When did RUBAGEN receive FDA 510(k) clearance?

RUBAGEN received FDA 510(k) clearance on 1989-08-21, under 510(k) number K893755.

Who is the listed applicant for RUBAGEN?

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

What is the FDA product code for RUBAGEN?

The FDA product code for RUBAGEN is LQN.

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Other records listing Biokit USA, 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.

K913467TOXOGENK910541BIOKIT RPRK904310RHEUMAGEN RF T-CONTROLK910539RHEUMAJET RFK910686RHEUMAJET CRPK904311RHEUMAGEN ASO T-CONTROL

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Related Devices (Code: LQN)

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.

K031490RUBELLACOLImmunostics Inc.,K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.

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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