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
697–720 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 27, 2018
Panther Fusion GBS Assay
K181156 · NJR
Diagenode
Microbiology · 87d
Cleared Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K180218 · OCC
Cepheid
Microbiology · 180d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · PMT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 91d
Cleared Jul 15, 2018
Solana Bordetella Complete Assay
K181029 · OZZ
Quidel Corporation
Microbiology · 88d
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