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510(k) K981237

Device
QUANTA LITE RIBOSOME P ELISA
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K981237
Product code
MQA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-05
Date received
1998-04-03
Regulation
866.5100
Classification name
Anti-ribosomal P Antibodies
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRYS C MYERS
Address
10180 Scripps Ranch Blvd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K950169RIBOSOMAL P EIA TEST SYSTEMHogan & Hartson1996-05-23

Legacy Summary#

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FDA Review#

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