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
673–696 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
K181700 · JTN
Hardy Diagnostics
Microbiology · 13d
Cleared Jul 06, 2018
CHROMID CARBA agar (CARB)
K181092 · JSO
Biomerieux S.A.
Microbiology · 72d
Cleared Jul 06, 2018
Elecsys BRAHMS PCT
K173927 · PRI
Roche Diagnostics
Microbiology · 192d
Cleared Jul 05, 2018
FilmArray Blood Culture Identification (BCID) Panel
K181493 · PEN
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Jul 03, 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
K180936 · JWY
Biomerieux S.A.
Microbiology · 84d
Cleared Jun 26, 2018
NeuMoDx GBS Assay
K173725 · NJR
Neumodx Molecular, Inc.
Microbiology · 203d
Cleared Jun 22, 2018
OSOM Mono Test
K181436 · KTN
SEKISUI Diagnostics, LLC
Microbiology · 21d
Cleared Jun 20, 2018
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
K181368 · NGZ
bioMerieux, Inc.
Microbiology · 28d
Cleared Jun 14, 2018
ASI Evolution
K173376 · GMQ
Arlington Scientific, Inc. (Asi)
Microbiology · 227d
Cleared Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
K180681 · LSL
Hologic, Inc.
Microbiology · 90d
Cleared Jun 01, 2018
PanNAT STEC Test
K173330 · PCI
Micronics, Inc.
Microbiology · 221d
Cleared May 24, 2018
T2Bacteria Panel
K172708 · QBX
T2biosystems, Inc.
Microbiology · 258d
Cleared May 18, 2018
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
K180886 · JWY
Liofilchem S. R. L.
Microbiology · 44d
Cleared May 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K180264 · LSR
Gold Standard Diagnostics
Microbiology · 92d
Cleared May 02, 2018
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · PGX
Alere Scarborough, Inc.
Microbiology · 155d
Cleared May 01, 2018
BacterioScan 216Dx System
K172412 · QBQ
Bacterioscan, Inc.
Microbiology · 264d
Cleared Apr 26, 2018
Xpert Xpress Strep A
K173398 · PGX
Cepheid
Microbiology · 177d
Not Cleared Apr 20, 2018
MALDI Biotyper CA System
DEN170081 · QBN
Bruker Daltonik GmbH
Microbiology · 203d
Cleared Apr 04, 2018
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
K180339 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Not Cleared Apr 03, 2018
Curetis Unyvero LRT Application
DEN170047 · QBH
Curetis GmbH
Microbiology · 204d
Cleared Mar 23, 2018
UriSwab-Urine Collection, Transport and Preservation System
K180052 · JSM
Copan Italia Spa
Microbiology · 74d
Cleared Mar 22, 2018
Granada Medium
K173903 · PQZ
Hardy Diagnostics
Microbiology · 90d
Cleared Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Mar 20, 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K180438 · PSZ
Bd
Microbiology · 28d