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FDA 510(k)

ENZYGNOST TM RUBELLA IGM

K-Number: K813493 · 1982-03-04

ApplicantCalbiochem-Behring Corp.
Decision Date1982-03-04
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST TM RUBELLA IGM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K813493. 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 ENZYGNOST TM RUBELLA IGM?

ENZYGNOST TM RUBELLA IGM is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K813493.

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

ENZYGNOST TM RUBELLA IGM received FDA 510(k) clearance on 1982-03-04, under 510(k) number K813493.

Who is the listed applicant for ENZYGNOST TM RUBELLA IGM?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYGNOST TM RUBELLA IGM?

The FDA product code for ENZYGNOST TM RUBELLA IGM is LFX.

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Other records listing Calbiochem-Behring Corp. as applicant

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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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