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FDA 510(k)

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM

K-Number: K911444 · 1991-08-30

ApplicantWampole Laboratories
Decision Date1991-08-30
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K911444. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM?

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Wampole Laboratories. The 510(k) number is K911444.

When did RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM receive FDA 510(k) clearance?

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM received FDA 510(k) clearance on 1991-08-30, under 510(k) number K911444.

Who is the listed applicant for RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM?

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

What is the FDA product code for RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM?

The FDA product code for RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM is LFX.

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Other records listing Wampole Laboratories 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.

K965131BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMK965129BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMK882896ONE-STEP HCGK883004MONO-PLUS(TM)K875101VIROGEN CMV ANTIBODY TESTK875161MAT (TM) MICROALBUMIN TEST

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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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