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FDA 510(k)

PLATELIA RUBELLA IGG KIT

K-Number: K894946 · 1989-12-21

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1989-12-21
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PLATELIA RUBELLA IGG KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K894946. 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 PLATELIA RUBELLA IGG KIT?

PLATELIA RUBELLA IGG KIT is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K894946.

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

PLATELIA RUBELLA IGG KIT received FDA 510(k) clearance on 1989-12-21, under 510(k) number K894946.

Who is the listed applicant for PLATELIA RUBELLA IGG KIT?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLATELIA RUBELLA IGG KIT?

The FDA product code for PLATELIA RUBELLA IGG KIT is LFX.

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Other records listing Kallestad Diag, A Div. of Erbamont, Inc. 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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