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FDA 510(k)

RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540

K-Number: K860145 · 1986-07-14

ApplicantClinical Sciences, Inc.
Decision Date1986-07-14
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K860145. 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 ELISA TEST SYSTEM CATALOG NUMBER: 4540?

RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K860145.

When did RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 receive FDA 510(k) clearance?

RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 received FDA 510(k) clearance on 1986-07-14, under 510(k) number K860145.

Who is the listed applicant for RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540?

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

What is the FDA product code for RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540?

The FDA product code for RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 is LFX.

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Other records listing Clinical Sciences, Inc. as applicant

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K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITK883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550

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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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