510(k) DEN130049

Device: SIMPLEXA HSV 1&2 DIRECT
Applicant: Focus Diagnostics
510(k) number: DEN130049
Product code: PGH
Decision: Unknown (DENG)
Decision date: 2014-03-21
Date received: 2013-11-25
Regulation: 866.3307
Classification name: Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Direct
Third party reviewed: N

Applicant Contact#

Contact: SHARON YOUNG
Address: 11331 Valley View St. Cypress CA US 90630 90630

FDA Registration Numbers#

2023365

Source Documents#

510(k) summary PDF not indicated by FDA

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
20816101025514	Simplexa™ HSV 1 & 2 Positive Control Pack	DIASORIN MOLECULAR LLC	2016-09-22
20816101025507	Simplexa™ HSV 1 & 2 Direct	DIASORIN MOLECULAR LLC	2016-09-22

Other 510(k) Records For Product Code PGH#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K250050	miDiagnostics HSV-1&2 CSF Test	Midiagnostics NV	2025-09-30
K141458	SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK	Focus Diagnostics	2014-07-01