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510(k) K950169

Device
RIBOSOMAL P EIA TEST SYSTEM
Applicant
HOGAN & HARTSON
510(k) number
K950169
Product code
MQA  
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-23
Date received
1995-01-17
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
EDWARD C WILSON, JR.
Address
Columbia Sq. 555 Thirteenth St., NW Washington, D.C. DC US 20004 20004

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
K202540EliA Rib-PPhadia AB2021-09-13
K024151EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN PTheratest Laboratories, Inc.2003-02-06
K981237QUANTA LITE RIBOSOME P ELISAInova Diagnostics, Inc.1998-06-05

Legacy Summary#

summary

FDA Review#

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