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FDA 510(k)

ELISA RUBELLA IGM

K-Number: K914420 · 1991-12-27

ApplicantSclavo, Inc.
Decision Date1991-12-27
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ELISA RUBELLA IGM is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K914420. 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 ELISA RUBELLA IGM?

ELISA RUBELLA IGM is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Sclavo, Inc.. The 510(k) number is K914420.

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

ELISA RUBELLA IGM received FDA 510(k) clearance on 1991-12-27, under 510(k) number K914420.

Who is the listed applicant for ELISA RUBELLA IGM?

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

What is the FDA product code for ELISA RUBELLA IGM?

The FDA product code for ELISA RUBELLA IGM is LFX.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)K880049CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE

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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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