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510(k) K143651

Device
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Applicant
FOCUS DIAGNOSTICS, INC.
510(k) number
K143651
Product code
PGX  
Decision
Substantially Equivalent (SESE)
Decision date
2015-03-18
Date received
2014-12-23
Regulation
866.2680
Classification name
Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
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 PGX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201269Accula Strep A TestMesa Biotech, Inc.2020-11-09
K183366GenePOC Strep AGenepoc, Inc.2019-03-06
K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.2018-05-02
K173398Xpert Xpress Strep ACepheid2018-04-26
K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation2017-10-30
K172126Xpert Xpress Strep ACepheid2017-09-25
K162274Solana Strep Complete AssayQuidel Corporation2016-10-25
K150868Solana GAS Assay, Solana instrumentQuidel Corporation2015-06-23
K141757ALERE I STREP AAlere Scarborough, Inc.2015-03-31
K141338LIAT STREP A ASSAYIquum, Inc.2014-11-04
K141173AMPLIVUE GAS ASSAYQuidel Corporation2014-07-24
DEN140005LYRA DIRECT STREP ASSAYQuidel Corporation2014-04-16

Legacy Summary#

summary

FDA Review#

Decision Summary