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
745–768 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 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 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
Cleared Jul 10, 2017
TRI-COMBO PARASITE SCREEN
K171078 · MHJ
Techlab, Inc.
Microbiology · 90d
Cleared Jun 29, 2017
Rickettsia Real-time PCR Assay
K170940 · PVQ
Centers For Disease Control and...
Microbiology · 91d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · LGD
Roche Diagnostics
Microbiology · 270d
Cleared Jun 22, 2017
FilmArray NGDS Warrior Panel
K170883 · PRD
Biofire Defense, LLC
Microbiology · 90d