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
1177–1200 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · LON
bioMerieux, Inc.
Microbiology · 321d
Cleared Nov 16, 2011
VIZION
K112276 · JWY
Trek Diagnostic Systems
Microbiology · 99d
Cleared Nov 09, 2011
ASIMANAGER - AT
K111356 · JQT
Arlington Scientific, Inc.
Microbiology · 177d
Cleared Nov 08, 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
K111615 · JWY
Trek Diagnostic Systems
Microbiology · 151d
Cleared Oct 28, 2011
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277 · PSZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 24, 2011
SOFIA ANALYZER AND INFLUENZA A+B FIA
K112177 · PSZ
Quidel Corp.
Microbiology · 88d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684 · JSO
Bio-Rad
Microbiology · 308d
Cleared Oct 20, 2011
BD GENEOHM VANR ASSAY
K102416 · NIJ
Bd Diagnostics Science
Microbiology · 422d
Cleared Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 18, 2011
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
K112586 · JTN
Becton, Dickinson and Company (BD)
Microbiology · 42d
Cleared Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · LON
bioMerieux, Inc.
Microbiology · 295d
Cleared Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Sep 27, 2011
ISOAMP HSV ASSAY
K111951 · OQO
Biohelix Corporation
Microbiology · 81d
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · LON
bioMerieux, Inc.
Microbiology · 63d
Cleared Sep 22, 2011
SENSITITRE OPTIREAD
K110583 · LRG
Trek Diagnostic Systems, Ltd.
Microbiology · 205d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A&B DETECTION KIT
K111775 · OCC
U.S. Army Medical Material...
Microbiology · 82d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A SUBTYPING KIT
K111778 · OQW
U.S Army Medical Materiel Development...
Microbiology · 82d
Cleared Sep 01, 2011
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
K112199 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 31d
Cleared Aug 26, 2011
AUTOREADER 2
K103532 · LRG
Trek Diagnostic Systems
Microbiology · 268d
Cleared Aug 25, 2011
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
K101234 · OWF
Ventana Medical Systems, Inc.
Microbiology · 479d
Cleared Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K111072 · OPL
Bio-Rad Laboratories
Microbiology · 127d
Cleared Aug 23, 2011
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K111507 · OQW
Centers For Disease Control and...
Microbiology · 83d