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
385–408 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924 · MYF
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923 · MXJ
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911 · LFZ
Roche Diagnostics
Microbiology · 197d
Cleared Oct 05, 2022
Colibrí System
K220546 · LON
Copan Wasp Srl
Microbiology · 222d
Cleared Sep 21, 2022
BD MAX Enteric Viral Panel
K220607 · PCH
Becton, Dickinson and Company
Microbiology · 203d
Cleared Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 672d
Cleared Sep 13, 2022
Simplexa COVID-19 Direct
K212147 · QQX
Diasorin Molecular, LLC
Microbiology · 431d
Cleared Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K222558 · PBK
Centers For Disease Control and...
Microbiology · 6d
Cleared Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262 · PRI
Siemens Healthcare Diagnostics, Inc.
Microbiology · 207d
Cleared Aug 19, 2022
BD MAX Enteric Parasite Panel
K220193 · PCH
Becton, Dickinson and Company
Microbiology · 207d
Cleared Aug 19, 2022
Viramed Borrela All-In-One ViraChip Test Kit
K220016 · LSR
Viramed Biotech AG
Microbiology · 226d
Cleared Aug 18, 2022
iClean Viral Transport System (VTM-RT kit)
K212856 · JSM
Huachenyang (Shenzhen) Technology Co....
Microbiology · 344d
Cleared Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
K212243 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Aug 08, 2022
Dasky Disposable Sampling Tube (Model name: VSM02)
K211675 · QBD
Ningbo Dasky Life Science Co., Ltd.
Microbiology · 433d
Cleared Jul 28, 2022
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
K214122 · PCI
Becton, Dickinson and Company
Microbiology · 210d
Cleared Jul 28, 2022
MagXtract Collection Tube
K212113 · QBD
Magbio Genomics, Inc.
Microbiology · 386d
Cleared Jul 25, 2022
BioFire COVID-19 Test 2
K221460 · QQX
Biofire Defense, LLC
Microbiology · 67d
Cleared Jul 22, 2022
BioFire JI Control Panel M420
K203680 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 582d
Cleared Jul 15, 2022
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....
K212778 · QLX
Abbott Molecular, Inc.
Microbiology · 317d
Cleared Jul 14, 2022
LIAISON MeMed BV, LIAISON MeMed BV Control Set
K213936 · QPS
DiaSorin, Inc.
Microbiology · 210d
Cleared Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS...
K213899 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Jul 11, 2022
Revogene
K220480 · OOI
Meridian Bioscience, Inc.
Microbiology · 143d
Cleared Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
K213822 · OCC
Roche Molecular Systems, Inc.
Microbiology · 210d
Cleared Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221834 · PBK
Centers For Disease Control and...
Microbiology · 1d