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FDA 510(k)

RUBELLA IGM ELISA TEST

K-Number: K904084 · 1990-12-04

ApplicantGull Laboratories, Inc.
Decision Date1990-12-04
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA IGM ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1990-12-04 under 510(k) number K904084. 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 IGM ELISA TEST?

RUBELLA IGM ELISA TEST is a medical device that received FDA 510(k) clearance on 1990-12-04. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K904084.

When did RUBELLA IGM ELISA TEST receive FDA 510(k) clearance?

RUBELLA IGM ELISA TEST received FDA 510(k) clearance on 1990-12-04, under 510(k) number K904084.

Who is the listed applicant for RUBELLA IGM ELISA TEST?

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

What is the FDA product code for RUBELLA IGM ELISA TEST?

The FDA product code for RUBELLA IGM ELISA TEST is LFX.

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Other records listing Gull Laboratories, Inc. as applicant

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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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