510(k) K063565

Device: QUANTA LITE SS-A 52 ELISA
Applicant: INOVA DIAGNOSTICS, INC.
510(k) number: K063565
Product code: OBE
Decision: Substantially Equivalent (SESE)
Decision date: 2007-04-04
Date received: 2006-11-28
Regulation: 866.5100
Classification name: Anti-ss-a 52 Autoantibodies
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: 9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

2026994
3012348571

Source Documents#

510(k) summary PDF not indicated by FDA

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08426950544135	QUANTA Lite® SS-A 52 ELISA	INOVA DIAGNOSTICS, INC.	2016-08-31

Other 510(k) Records For Product Code OBE #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K250814	Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB	Zeus Scientific	2026-05-08
K141655	QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS	Inova Diagnostics, Inc.	2015-03-05

Legacy Summary#

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FDA Review#

Decision Summary