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FDA 510(k)

ORTHO RUBELLA ELISA TEST SYSTEM

K-Number: K822342 · 1983-03-17

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1983-03-17
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO RUBELLA ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K822342. 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 ORTHO RUBELLA ELISA TEST SYSTEM?

ORTHO RUBELLA ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K822342.

When did ORTHO RUBELLA ELISA TEST SYSTEM receive FDA 510(k) clearance?

ORTHO RUBELLA ELISA TEST SYSTEM received FDA 510(k) clearance on 1983-03-17, under 510(k) number K822342.

Who is the listed applicant for ORTHO RUBELLA ELISA TEST SYSTEM?

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

What is the FDA product code for ORTHO RUBELLA ELISA TEST SYSTEM?

The FDA product code for ORTHO RUBELLA ELISA TEST SYSTEM is LFX.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 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.

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