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
769–792 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 16, 2017
Solana RSV+hMPV Assay
K171974 · OCC
Quidel Corporation
Microbiology · 108d
Cleared Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K172454 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Sep 29, 2017
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B...
K171792 · OCC
Alere Scarborough, Inc.
Microbiology · 105d
Cleared Sep 27, 2017
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
K172109 · JWY
Liofilchem S. R. L.
Microbiology · 76d
Cleared Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit,...
K171963 · OCC
Hologic, Inc.
Microbiology · 88d
Cleared Sep 25, 2017
Xpert Xpress Strep A
K172126 · PGX
Cepheid
Microbiology · 73d
Cleared Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
K172150 · JWY
bioMerieux, Inc.
Microbiology · 60d
Cleared Sep 12, 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · OZN
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC...
K172274 · JWY
Thermo Fisher Scientific
Microbiology · 33d
Cleared CT Aug 30, 2017
Idylla Respiratory (IFV-RSV) Panel
K163628 · OCC
Janssen Pharmaceutica NV
Microbiology · 251d
Cleared Aug 22, 2017
Borrelia B31 ViraChip IgM Test Kit
K163695 · LSR
Viramed Biotech AG
Microbiology · 237d
Cleared Aug 21, 2017
RIDA GENE Norovirus GI/GII
K171511 · PIQ
R-Biopharm AG
Microbiology · 89d
Not Cleared Aug 18, 2017
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax...
DEN160025 · PYN
Id-Fish Technology, Inc.
Microbiology · 417d
Cleared Aug 09, 2017
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K172091 · OZE
Centers For Disease Control and...
Microbiology · 29d
Cleared Aug 08, 2017
iC-GPC Assay TM for use on the iC-SystemTM
K163390 · PAM
Icubate, Inc.
Microbiology · 249d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · JTN
Hardy Diagnostics
Microbiology · 32d
Cleared Aug 01, 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
K171906 · JWY
Liofilchem S. R. L.
Microbiology · 36d
Cleared Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K171870 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Jul 26, 2017
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K163536 · PEX
Bruker Daltonik GmbH
Microbiology · 222d
Cleared Jul 22, 2017
VITEK MS
K162950 · PEX
bioMerieux, Inc.
Microbiology · 271d
Cleared CT Jul 21, 2017
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File...
K171441 · OZN
Luminex Corporation
Microbiology · 66d
Cleared Jul 12, 2017
Great Basin Stool Bacterial Pathogens Panel
K163571 · PCI
Great Basin Scientific, Inc.
Microbiology · 205d
Cleared Jul 12, 2017
Borrelia B31 ViraChip IgG Test Kit
K163504 · LSR
Viramed Biotech AG
Microbiology · 210d