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FDA 510(k)

FIAGEN RUBELLA IGG

K-Number: K883182 · 1988-10-31

ApplicantCyberfluor, Inc.
Decision Date1988-10-31
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAGEN RUBELLA IGG is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1988-10-31 under 510(k) number K883182. 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 FIAGEN RUBELLA IGG?

FIAGEN RUBELLA IGG is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K883182.

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

FIAGEN RUBELLA IGG received FDA 510(k) clearance on 1988-10-31, under 510(k) number K883182.

Who is the listed applicant for FIAGEN RUBELLA IGG?

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

What is the FDA product code for FIAGEN RUBELLA IGG?

The FDA product code for FIAGEN RUBELLA IGG is LFX.

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Other records listing Cyberfluor, 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.

K923410FIAGEN PROGESTERONEK905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYK904539FLAGEN TM FREE T4K900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K895396CYBERFLUOR FIAGEN TSH

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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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