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
217–240 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
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