FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1249–1272 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 24, 2010
SIMPLEXA FLU A/B & RSV
K102170 · OCC
Focus Diagnostics, Inc.
Microbiology · 114d
Cleared Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
K102668 · JWY
BIOMERIEUX
Microbiology · 62d
Cleared Nov 10, 2010
BIOSIGN FLU A+B
K083746 · PSZ
Princeton BioMeditech Corp.
Microbiology · 693d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · JSO
Bio-Rad
Microbiology · 241d
Cleared Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
K102314 · OOI
Focus Diagnostics, Inc.
Microbiology · 74d
Cleared Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
K093076 · LON
bioMerieux, Inc.
Microbiology · 386d
Cleared Oct 08, 2010
REMEL SPECTRA MRSA
K092407 · JSO
Remel, Inc.
Microbiology · 428d
Cleared Oct 05, 2010
ANTI-HAV
K100903 · LOL
Roche Professional Diagnostics
Microbiology · 187d
Cleared Oct 01, 2010
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
K093837 · LIP
Zeus Scientific, Inc. (Zeus)
Microbiology · 290d
Cleared Sep 29, 2010
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
K093834 · MSQ
Hema Metrics, LLC
Microbiology · 289d
Cleared Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
K101566 · NGZ
bioMerieux, Inc.
Microbiology · 116d
Cleared Sep 24, 2010
QUICKVUE RSV 10
K101918 · GQG
Quidel Corp.
Microbiology · 77d
Cleared Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425 · LRG
Siemens Healthcare Diagnostics
Microbiology · 113d
Cleared Aug 25, 2010
ETEST MOXIFLOXACIN 0.002-32 UG/ML
K093604 · JWY
Ab Biomerieux
Microbiology · 278d
Cleared Aug 20, 2010
BBL CHROMAGAR MRSA II
K092767 · JSO
Becton, Dickinson & CO
Microbiology · 345d
Cleared Jul 28, 2010
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
K101879 · NQX
Cepheid
Microbiology · 22d
Cleared Jul 23, 2010
PROFAST+ ASSAY
K101855 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 22d
Cleared Jul 22, 2010
AUDIT MICROCV PROCALCITONIN LINEARITY
K101434 · MJX
Aalto Scientific, Ltd.
Microbiology · 62d
Cleared Jul 16, 2010
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
K093784 · OPM
Zeus Scientific, Inc.
Microbiology · 219d
Cleared Jul 15, 2010
REMEL SPECTRA VRE
K092819 · JSO
Thermo Fisher Scientific
Microbiology · 304d
Cleared Jul 15, 2010
YEAST TRAFFIC LIGHT PNA FISH
K093024 · NZS
Advandx, Inc.
Microbiology · 289d
Cleared Jul 09, 2010
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL...
K100818 · OMN
Meridian Bioscience, Inc.
Microbiology · 108d
Cleared Jul 09, 2010
BD DIRECTIGEN EZ RSV
K101514 · GQG
Becton, Dickinson & CO
Microbiology · 37d
Cleared Jul 06, 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT,...
K091409 · NQX
Roche Molecular Systems, Inc.
Microbiology · 419d