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
1105–1128 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
K123266 · LON
Becton, Dickinson and Company
Microbiology · 250d
Cleared Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914 · PEN
Biofire Diagnostics, Inc.
Microbiology · 80d
Cleared Jun 20, 2013
XPERT MRSA/SA BLOOD CULTURE ASSAY
K130894 · NQX
Cepheid
Microbiology · 80d
Cleared Jun 17, 2013
SOFIA STREP A FIA
K123793 · GTY
Quidel Corporation
Microbiology · 189d
Cleared Jun 05, 2013
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA...
K123423 · OZX
Meridian Bioscience, Inc.
Microbiology · 211d
Cleared Jun 04, 2013
VIDAS LYME IGM
K122979 · LSR
Biomerieux S.A.
Microbiology · 251d
Cleared May 22, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K130551 · OQW
Centers For Disease Control and...
Microbiology · 79d
Cleared CT May 22, 2013
BREATHID HP SYSTEM
K130524 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 83d
Cleared May 13, 2013
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K123903 · MDB
Becton, Dickinson & CO
Microbiology · 145d
Cleared Apr 02, 2013
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
K130470 · OZN
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 36d
Cleared CT 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