FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
217–240 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 07, 2024
ADVIA Centaur EBV-EBNA IgG
K233605 · LLM
Biokit, S.A.
Microbiology · 272d
Cleared Aug 02, 2024
Viral Transport Medium
K233534 · JSM
Hardy Diagnostics
Microbiology · 273d
Cleared Jul 30, 2024
Nano-Check™ RSV Test
K240280 · GQG
Nano-Ditech Corporation
Microbiology · 180d
Cleared Jul 24, 2024
Aptima HCV Quant Dx Assay
K233352 · MZP
Hologic, Inc.
Microbiology · 299d
Cleared Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · QOF
Hologic, Inc.
Microbiology · 76d
Cleared Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · JTN
Hardy Diagnostics
Microbiology · 91d
Cleared Jul 15, 2024
Avantik VTM
K233449 · JSM
Hanchang Medic Co., Ltd. (Han Chang...
Microbiology · 269d
Not Cleared Jul 15, 2024
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa...
DEN230092 · SBT
Diasorin Molecular, LLC
Microbiology · 200d
Cleared Jul 10, 2024
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
K233453 · QQX
Life Technologies Corporation
Microbiology · 264d
Not Cleared Jun 27, 2024
Xpert HCV
DEN240016 · SBP
Cepheid
Microbiology · 72d
Cleared Jun 26, 2024
Sample Preservative Fluid
K222771 · QBD
Hangzhou Bioer Technology Co., Ltd.
Microbiology · 651d
Cleared Jun 21, 2024
CorDx Tyfast COVID-19 Ag Rapid Test
K240728 · QYT
CorDx, Inc.
Microbiology · 95d
Cleared Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K230675 · SAN
Specific Diagnostics, LLC
Microbiology · 468d
Cleared Jun 17, 2024
Molecular Transport Media - MTM
K233324 · QBD
Alb Luz
Microbiology · 262d
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