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
1441–1464 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Jan 04, 2008
PROFLU+ ASSAY
K073029 · OCC
Prodesse, Inc.
Microbiology · 67d
Not Cleared Jan 03, 2008
ID-TAG RESPIRATORY VIRAL PANEL
DEN070013 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 30d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · LLH
bioMerieux, Inc.
Microbiology · 141d
Cleared Dec 20, 2007
BD GENEOHM STAPHSR ASSAY
K071026 · NQX
Bd Diagnostics (Geneohm Sciences...
Microbiology · 253d
Cleared Dec 20, 2007
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
K072631 · NHT
Idaho Technology, Inc.
Microbiology · 93d
Cleared Dec 19, 2007
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
K072547 · OEH
Idaho Technology, Inc.
Microbiology · 100d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083 · LON
bioMerieux, Inc.
Microbiology · 39d
Cleared Nov 26, 2007
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
K072827 · MJE
Remel, Inc.
Microbiology · 54d
Cleared Nov 20, 2007
BBL CHROMAGAR 0157
K070691 · JSI
Becton, Dickinson & CO
Microbiology · 252d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Nov 15, 2007
TRU FLU
K071657 · PSZ
Meridian Bioscience, Inc.
Microbiology · 150d
Cleared Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING...
K070265 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 268d
Cleared Oct 18, 2007
TRU RSV
K071101 · GOG
Meridian Bioscience, Inc.
Microbiology · 182d
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668 · LON
bioMerieux, Inc.
Microbiology · 24d
Cleared Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
K071146 · NTM
bioMerieux, Inc.
Microbiology · 170d
Cleared Oct 05, 2007
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
K071511 · MXJ
Focus Diagnostics, Inc.
Microbiology · 123d
Cleared Oct 02, 2007
MODIFICATION TO BIOSTAR OIA SHIGATOX
K071799 · GNA
Iverness Medical Professional...
Microbiology · 92d
Cleared Sep 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675 · LJP
Diagnostic Hybrids, Inc.
Microbiology · 287d
Cleared Sep 24, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
K070809 · LON
Becton, Dickinson & CO
Microbiology · 182d
Cleared Sep 24, 2007
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
K071510 · MXJ
Focus Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 21, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL...
K063798 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 273d
Cleared Sep 13, 2007
MRSASELECT
K070361 · JSO
Bio-Rad
Microbiology · 218d
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038 · LON
bioMerieux, Inc.
Microbiology · 49d