FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
241–264 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 31, 2024
iHealth COVID-19 Antigen Rapid Test
K233842 · QYT
Ihealth Labs, Inc.
Microbiology · 179d
Cleared May 31, 2024
QIAstat-Dx Gastrointestinal Panel 2
K220062 · PCH
QIAGEN GmbH
Microbiology · 872d
Cleared May 30, 2024
SPOTFIRE RSP Pos & Neg Controls
K241289 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 23d
Cleared May 30, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
K241194 · QOF
Biofire Diagnostics, LLC
Microbiology · 30d
Cleared May 29, 2024
EasyScreen Gastrointestinal Parasite Detection Kit
K232672 · PCH
Genetic Signatures Limited
Microbiology · 271d
Cleared May 21, 2024
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A...
K241110 · OZE
Centers For Disease Control and...
Microbiology · 29d
Cleared May 16, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K240445 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared May 10, 2024
QIAstat-Dx® Respiratory Panel Plus
K233100 · QOF
QIAGEN GmbH
Microbiology · 227d
Cleared May 03, 2024
Alinity m HSV 1 & 2 / VZV
K233349 · PGI
Abbott Molecular, Inc.
Microbiology · 217d
Cleared May 03, 2024
Viral Transport Media (VTM)
K232454 · JSM
Alb Luz
Microbiology · 263d
Cleared Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
K221688 · SAN
Q-Linea AB
Microbiology · 686d
Cleared Apr 25, 2024
Copan Universal Transport Medium (UTM-RT) System
K232357 · JSM
Copan Italia Spa
Microbiology · 262d
Cleared Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
K233373 · QYT
ACON Laboratories, Inc.
Microbiology · 200d
Cleared Apr 19, 2024
Healgen Rapid COVID-19 Antigen Test
K232377 · QVF
Healgen Scientific, LLC
Microbiology · 255d
Cleared Apr 11, 2024
Azer Scientific Universal Transport Medium
K202531 · JSM
Azer Scientific, Inc.
Microbiology · 1318d
Cleared Apr 08, 2024
Sample preservation solution
K212878 · QBD
Zhejiang Gene Science Co., Ltd.
Microbiology · 942d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · SAN
Affinity Biosensors
Microbiology · 1026d
Cleared Mar 27, 2024
ARX Liquid Amies Collection & Transport System
K222613 · LIO
Arx Sciences, Inc.
Microbiology · 575d
Cleared Mar 26, 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control...
K233611 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 134d
Cleared Mar 26, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
K232954 · QOF
Biofire Diagnostics, LLC
Microbiology · 187d
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