Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201

K-Number: K881243 · 1988-04-04

ApplicantLabsystems, Inc.
Decision Date1988-04-04
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 is the device name listed in this FDA 510(k) record. The listed applicant is Labsystems, Inc.. It received FDA 510(k) clearance on 1988-04-04 under 510(k) number K881243. 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 RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201?

RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 is a medical device that received FDA 510(k) clearance on 1988-04-04. The listed applicant is Labsystems, Inc.. The 510(k) number is K881243.

When did RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 receive FDA 510(k) clearance?

RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 received FDA 510(k) clearance on 1988-04-04, under 510(k) number K881243.

Who is the listed applicant for RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201?

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

What is the FDA product code for RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201?

The FDA product code for RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Labsystems, 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.

K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMK896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIAK890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIAK890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITK873780MODIFICATION RUBELLA IGM EIA TEST KITK873583AUTO-EIA

View all 17 devices →

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.

↑