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
1081–1104 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 21, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP...
K121894 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 265d
Cleared Mar 14, 2013
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Mar 08, 2013
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
K123998 · OZN
Quidel Corp.
Microbiology · 72d
Cleared Mar 08, 2013
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
K123955 · OOI
Life Technologies Corporation
Microbiology · 77d
Cleared Mar 08, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K122189 · OEM
Quidel Corp.
Microbiology · 227d
Cleared Mar 05, 2013
VIDAS LYME IGG
K122986 · LSR
Biomerieux S.A.
Microbiology · 160d
Cleared Mar 01, 2013
UNIGOLD GIARDIA
K120001 · MHI
Trinity Biotech
Microbiology · 423d
Cleared Feb 11, 2013
FILMARRAY RESPIRATORY PANEL (RP)
K123620 · OCC
Biofire Diagnostics, Inc.
Microbiology · 80d
Cleared Feb 08, 2013
ADENOVIRUS R-GENE US
K121942 · OCC
Argene SA
Microbiology · 221d
Cleared Feb 08, 2013
UNI-GOLD CRYPTOSPORIDIUM
K121565 · MHJ
Trinity Biotech
Microbiology · 255d
Cleared Feb 06, 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
K122718 · GTY
Becton, Dickinson and Company
Microbiology · 154d
Cleared Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · MDB
bioMerieux, Inc.
Microbiology · 254d
Cleared Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · MDB
bioMerieux, Inc.
Microbiology · 255d
Cleared Jan 22, 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461 · MDB
bioMerieux, Inc.
Microbiology · 250d
Cleared Jan 16, 2013
PRO HMPV+ ASSAY
K123838 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 34d
Cleared Jan 16, 2013
PROGASTRO SSCS ASSAY
K123274 · PCH
Gen-Probe Prodesse, Inc.
Microbiology · 89d
Cleared Jan 14, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K123905 · OQW
Centers For Disease Control and...
Microbiology · 26d
Not Cleared Jan 14, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR...
DEN130003 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 3d
Cleared Jan 09, 2013
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
K122062 · OUY
Gen-Probe, Inc.
Microbiology · 180d
Cleared Jan 07, 2013
ENTEROCOCCUS QUICKFISH BC
K121991 · OAH
Advandx, Inc.
Microbiology · 185d
Cleared Dec 27, 2012
XPERT CT/NG
K121710 · LSL
Cepheid
Microbiology · 199d
Cleared Dec 21, 2012
XPERT FLU
K123191 · OCC
Cepheid
Microbiology · 71d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Dec 17, 2012
ALPHA CRYPTOCOCCAL ANTIGEN EIA
K120946 · MDU
Immuno-Mycologics, Inc.
Microbiology · 263d