FDA.reportPublic FDA data

510(k) K202540

Device
EliA Rib-P
Applicant
Phadia AB
510(k) number
K202540
Product code
MQA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-13
Date received
2020-09-02
Regulation
866.5100
Classification name
Anti-ribosomal P Antibodies
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carina Magnusson
Address
Rapsgatan 7p Uppsala SE SE 754 50 SE 754 50

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K024151EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN PTheratest Laboratories, Inc.2003-02-06
K981237QUANTA LITE RIBOSOME P ELISAInova Diagnostics, Inc.1998-06-05
K950169RIBOSOMAL P EIA TEST SYSTEMHogan & Hartson1996-05-23

Legacy Summary#

summary

FDA Review#

Decision Summary