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
1249–1272 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 25, 2011
SMART LEISH, MODEL LGM1-050
K081868 · OUZ
U.S. Army Medical Research Institute...
Microbiology · 1057d
Cleared May 20, 2011
NUCLISENS EASYQ MRSA
K102740 · NQX
bioMerieux, Inc.
Microbiology · 240d
Cleared May 20, 2011
JBAIDS Q FEVER DETECTION KIT
K103207 · OVF
Idaho Technology, Inc.
Microbiology · 200d
Cleared May 20, 2011
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603 · MYF
Zeus Scientific, Inc.
Microbiology · 163d
Cleared May 18, 2011
VIDAS TOXO IGG AVIDITY
K101946 · LGD
bioMerieux, Inc.
Microbiology · 310d
Cleared CT May 17, 2011
RPS ADENO DETECTOR PLUS
K110722 · GOD
Rapid Pathogen Screening, Inc.
Microbiology · 63d
Cleared May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
K102535 · JWY
Biomerieux S.A.
Microbiology · 255d
Cleared May 05, 2011
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
K102342 · OUS
Microphage, Inc.
Microbiology · 260d
Cleared May 04, 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 229d
Cleared May 04, 2011
HARDYCHROM MRSA
K102922 · JSO
Hardy Diagnostics
Microbiology · 215d
Cleared May 03, 2011
PREMIER C. DIFFICILE GDH
K110620 · MCB
Meridian Bioscience, Inc.
Microbiology · 61d
Cleared Apr 27, 2011
SENSITITRE AIM (TM)
K110331 · LIE
Trek Diagnostic Systems, Ltd.
Microbiology · 83d
Cleared Apr 27, 2011
FILMARRAY RP PANEL
K110764 · OCC
Idaho Technology, Inc.
Microbiology · 40d
Cleared Apr 26, 2011
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
K103363 · MXJ
Zeus Scientific, Inc.
Microbiology · 160d
Cleared Apr 21, 2011
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM...
K103766 · OQW
Cepheid
Microbiology · 119d
Not Cleared Apr 19, 2011
APTIMA TRICHOMONAS VAGINALIS ASSAY
DEN110012 · OUY
Gen-Probe Incorporated
Microbiology · 6d
Not Cleared Apr 08, 2011
DENV DETECT IGM CAPTURE ELISA
DEN100020 · OSU
Inbios Intl., Inc.
Microbiology · 170d
Cleared Apr 07, 2011
XPERT C. DIFFICLE/EPI ASSAY
K110203 · OMN
Cepheid
Microbiology · 73d
Cleared Mar 18, 2011
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
K103798 · OQO
Becton, Dickinson & CO
Microbiology · 81d
Cleared Feb 24, 2011
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K110012 · OMN
Meridian Bioscience, Inc.
Microbiology · 52d
Not Cleared Feb 23, 2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA
DEN110001 · OUC
R-Biopharm AG
Microbiology · 7d
Cleared Feb 17, 2011
FILMARRAY RESPIRATORY PANEL (RP)
K103175 · OCC
Idaho Technology, Inc.
Microbiology · 112d
Cleared Feb 10, 2011
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283 · LIP
Zeus Scientific, Inc.
Microbiology · 182d
Cleared Jan 25, 2011
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES...
K103805 · LIO
Medical Wire & Equipment Company...
Microbiology · 28d