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FDA 510(k)

CHROMOTITRE E.I.A. RUBELLA IGG

K-Number: K872071 · 1987-08-24

ApplicantIsmunit Istituto Immunologico Intaliano
Decision Date1987-08-24
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHROMOTITRE E.I.A. RUBELLA IGG is the device name listed in this FDA 510(k) record. The listed applicant is Ismunit Istituto Immunologico Intaliano. It received FDA 510(k) clearance on 1987-08-24 under 510(k) number K872071. 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 CHROMOTITRE E.I.A. RUBELLA IGG?

CHROMOTITRE E.I.A. RUBELLA IGG is a medical device that received FDA 510(k) clearance on 1987-08-24. The listed applicant is Ismunit Istituto Immunologico Intaliano. The 510(k) number is K872071.

When did CHROMOTITRE E.I.A. RUBELLA IGG receive FDA 510(k) clearance?

CHROMOTITRE E.I.A. RUBELLA IGG received FDA 510(k) clearance on 1987-08-24, under 510(k) number K872071.

Who is the listed applicant for CHROMOTITRE E.I.A. RUBELLA IGG?

The FDA 510(k) record lists Ismunit Istituto Immunologico Intaliano as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMOTITRE E.I.A. RUBELLA IGG?

The FDA product code for CHROMOTITRE E.I.A. RUBELLA IGG is LFX.

Related Clinical Trials

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.

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Other records listing Ismunit Istituto Immunologico Intaliano 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.

K872070CHROMOTITRE E.I.A. TOXOPLASMA IGM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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