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FDA 510(k)

RUBELLA IGG

K-Number: K902793 · 1990-07-31

ApplicantPharmacia Diagnostics, Inc.
Decision Date1990-07-31
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA IGG is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K902793. 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 IGG?

RUBELLA IGG is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Pharmacia Diagnostics, Inc.. The 510(k) number is K902793.

When did RUBELLA IGG receive FDA 510(k) clearance?

RUBELLA IGG received FDA 510(k) clearance on 1990-07-31, under 510(k) number K902793.

Who is the listed applicant for RUBELLA IGG?

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

What is the FDA product code for RUBELLA IGG?

The FDA product code for RUBELLA IGG is LFX.

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Other records listing Pharmacia Diagnostics, 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.

K921011PHARMACIA CMV IGM ELISAK920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOK915348EBV-VCA IGM ELISAK914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSK912026DELFIA(R) 17 -OH-PROGESTERON KITK902792TOXOPLASMA GONDII IGG

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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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