Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
289–312 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 276d
Cleared Mar 22, 2024
QuickVue COVID-19 Test
K231795 · QYT
Quidel Corporation
Microbiology · 276d
Cleared Mar 19, 2024
ARX Viral Transport Media Collection and Transport System
K231843 · JSM
Arx Sciences, Inc.
Microbiology · 271d
Cleared Mar 15, 2024
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
K233986 · LON
Becton, Dickinson and Company
Microbiology · 88d
Cleared Mar 11, 2024
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
K234000 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Mar 11, 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
K231758 · QOF
Luminex Molecular Diagnostics, Inc.
Microbiology · 269d
Cleared Mar 01, 2024
LIAISON PLEX Respiratory Flex Assay
K233410 · QOF
Luminex Corporation
Microbiology · 147d
Cleared Feb 15, 2024
PBC Separator with Selux AST System
K223493 · QZX
Selux Diagnostics, Inc.
Microbiology · 451d
Cleared Feb 08, 2024
T2Bacteria® Panel
K233184 · QBX
T2biosystems, Inc.
Microbiology · 133d
Cleared Feb 08, 2024
eQUANT System
K231536 · QZX
Avails Medical, Inc.
Microbiology · 254d
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329 · LSL
Hologic, Inc.
Microbiology · 263d
Cleared Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
K231187 · QVF
Nano-Ditech Corporation
Microbiology · 272d
Cleared Dec 27, 2023
Colibrí
K232756 · LON
Copan Wasp Srl
Microbiology · 110d
Cleared Dec 22, 2023
NeuMoDx CT/NG Assay 2.0
K230267 · QEP
Neumodx Molecular, Inc.
Microbiology · 325d
Cleared Dec 21, 2023
KaiBiLi Extended ViralTrans
K231027 · JSM
Hangzhou Genesis Biodetection &...
Microbiology · 254d
Cleared Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286 · PGI
Quidel Corporation
Microbiology · 141d
Cleared Dec 15, 2023
Hp Detect™ Stool Antigen ELISA
K232892 · LYR
Biomerica, Inc.
Microbiology · 88d
Cleared CT Dec 15, 2023
SeptiCyte RAPID
K232095 · PRE
Immunexpress, Inc.
Microbiology · 155d
Cleared Dec 13, 2023
Sofia 2 SARS Antigen+ FIA
K233688 · QVF
Quidel Corporation
Microbiology · 26d
Cleared Dec 05, 2023
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
K232434 · PSZ
Bd
Microbiology · 116d
Cleared Dec 04, 2023
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K223783 · QWR
Roche Molecular Systems, Inc.
Microbiology · 353d
Cleared Nov 28, 2023
Cue COVID-19 Molecular Test
K232643 · QWB
Cue Health, Inc.
Microbiology · 90d
Cleared Nov 20, 2023
The SensiTox B. anthracis Toxin Test
K232545 · QUU
First Light Diagnostics, Inc.
Microbiology · 90d
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451 · MKZ
Hologic, Inc.
Microbiology · 268d