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
265–288 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 12, 2024
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
K232967 · NGZ
bioMerieux, Inc.
Microbiology · 265d
Cleared Jun 11, 2024
InActiv Blue
K221547 · QBD
Fertipro NV
Microbiology · 746d
Cleared Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
K232963 · NGZ
bioMerieux, Inc.
Microbiology · 260d
Cleared Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
K240627 · PEO
Luminex Corporation
Microbiology · 90d
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