FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1225–1248 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 18, 2011
VIDAS TOXO IGG AVIDITY
K101946 · LGD
bioMerieux, Inc.
Microbiology · 310d
Cleared 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
Cleared Jan 21, 2011
MAGO 4S
K093101 · LFX
Diamedix Corp.
Microbiology · 477d
Cleared Jan 21, 2011
LIAISON XL ANALYZER MODEL 10050
K103529 · LOL
DiaSorin, Inc.
Microbiology · 51d
Cleared Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
K093678 · NOM
Bio-Rad
Microbiology · 412d
Cleared Jan 10, 2011
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
K103209 · OCC
Nanosphere, Inc.
Microbiology · 70d