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
409–432 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 27, 2022
Architect CMV IgG
K220949 · LFZ
Abbott Laboratories
Microbiology · 209d
Cleared Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
K213804 · QQX
Roche Molecular Systems, Inc.
Microbiology · 320d
Cleared Oct 20, 2022
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global...
K220870 · QMV
Biofire Defense, LLC
Microbiology · 209d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · LON
bioMerieux, Inc.
Microbiology · 209d
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