FDA.reportPublic FDA data

510(k) K141458

Device
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
Applicant
FOCUS DIAGNOSTICS
510(k) number
K141458
Product code
PGH  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-01
Date received
2014-06-02
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PGH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250050miDiagnostics HSV-1&2 CSF TestMidiagnostics NV2025-09-30
DEN130049SIMPLEXA HSV 1&2 DIRECTFocus Diagnostics2014-03-21

Legacy Summary#

summary

FDA Review#

Decision Summary