FDA.reportPublic FDA data

510(k) K201269

Device
Accula Strep A Test
Applicant
Mesa Biotech, Inc.
510(k) number
K201269
Product code
PGX
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-09
Date received
2020-05-12
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
Dual Track
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Barbara Stevens
Address
6190 Cornerstone Ct. Suite 220 San Diego CA US 92121 92121

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
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
K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc.2015-03-18
K141338LIAT STREP A ASSAYIquum, Inc.2014-11-04
K141173AMPLIVUE GAS ASSAYQuidel Corporation2014-07-24
DEN140005LYRA DIRECT STREP ASSAYQuidel Corporation2014-04-16