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
241–264 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 13, 2024
T2Candida 1.1 Panel
K234063 · PII
T2biosystems, Inc.
Microbiology · 266d
Cleared Sep 06, 2024
Access Syphilis
K241427 · LIP
Beckman Coulter, Inc.
Microbiology · 109d
Cleared Aug 30, 2024
Alinity i Toxo IgM
K233932 · LGD
Abbott Laboratories
Microbiology · 260d
Cleared Aug 29, 2024
Ensol EnTM Specimen Collection and Transport System
K220908 · JSM
Ensol Biosciences, Inc.
Microbiology · 884d
Cleared Aug 28, 2024
VITROS Immunodiagnostic Products Syphilis Reagent Pack
K241534 · LIP
Ortho-Clinical Diagnostics
Microbiology · 90d
Cleared Aug 23, 2024
SCoV-2 Ag Detect Rapid Test
K233358 · QVF
InBios International, Inc.
Microbiology · 329d
Cleared Aug 19, 2024
OmniTrans Transport System
K240235 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 203d
Not Cleared Aug 16, 2024
First To Know Syphilis Test
DEN230090 · SBZ
Nowdiagnostics
Microbiology · 233d
Cleared Aug 12, 2024
iDart Lyme IgG ImmunoBlot Kit
K233367 · LSR
Id-Fish Technology, Inc.
Microbiology · 315d
Cleared Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
K233606 · LSE
Biokit, S.A.
Microbiology · 272d
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