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FDA 510(k)

RUBELLA IGM

K-Number: K921573 · 1992-08-27

ApplicantClark Laboratories, Inc.
Decision Date1992-08-27
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA IGM is the device name listed in this FDA 510(k) record. The listed applicant is Clark Laboratories, Inc.. It received FDA 510(k) clearance on 1992-08-27 under 510(k) number K921573. 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?

RUBELLA IGM is a medical device that received FDA 510(k) clearance on 1992-08-27. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K921573.

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

RUBELLA IGM received FDA 510(k) clearance on 1992-08-27, under 510(k) number K921573.

Who is the listed applicant for RUBELLA IGM?

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

What is the FDA product code for RUBELLA IGM?

The FDA product code for RUBELLA IGM is LFX.

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Other records listing Clark Laboratories, 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.

K980912VCA IGG ELISA TEST SYSTEMK980596VCA IGM ELISA TEST SYSTEMK980598EBNA-1 IGM ELISA TEST SYSTEMK973123EA-D IGG ELISA TEST SYSTEMK931543ENCORE ENA COMBINED EIAK925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA

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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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