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
1009–1032 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Not Cleared Apr 16, 2014
LYRA DIRECT STREP ASSAY
DEN140005 · PGX
Quidel Corporation
Microbiology · 22d
Cleared Apr 04, 2014
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · OZN
QIAGEN GmbH
Microbiology · 102d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · OQO
Quidel Corporation
Microbiology · 79d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL...
K133673 · OZZ
Meridian Bioscience, Inc.
Microbiology · 116d
Not Cleared Mar 21, 2014
SIMPLEXA HSV 1&2 DIRECT
DEN130049 · PGH
Focus Diagnostics
Microbiology · 116d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · LFZ
Roche Diagnostics
Microbiology · 270d
Cleared Feb 28, 2014
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K131334 · MXJ
Gold Standard Diagnostics
Microbiology · 295d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · LON
Becton, Dickinson and Company
Microbiology · 150d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343 · GTY
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 93d
Cleared Jan 31, 2014
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K133038 · NGZ
Trek Diagnostic Systems
Microbiology · 127d
Cleared Jan 17, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B...
K133869 · OZE
Center For Disease Control and...
Microbiology · 28d
Cleared Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843 · PEN
Nanosphere, Inc.
Microbiology · 120d
Cleared Jan 03, 2014
TRU FLU
K133714 · PSZ
Meridian Bioscience, Inc.
Microbiology · 29d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · LON
Becton, Dickinson and Company
Microbiology · 122d
Cleared Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
K133605 · NQX
Geneohm Sciences Canada, Inc.
Microbiology · 25d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503 · NJR
Quidel Corporation
Microbiology · 36d
Cleared Dec 18, 2013
ALERE INFLUENZA A & B TEST
K133637 · PSZ
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 41d
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · PSZ
Princeton BioMeditech Corp.
Microbiology · 28d
Cleared Dec 05, 2013
ALERE BINAXNOW INFLUENZA A & B CARD
K133411 · GNX
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270 · LSL
Roche Molecular Systems, Inc.
Microbiology · 133d
Cleared Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726 · OZN
Primeradx
Microbiology · 91d
Cleared Nov 26, 2013
BD MAX STAPHSR ASSAY, INSTRUMENT
K132822 · NQX
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 78d
Cleared Nov 21, 2013
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831 · PEX
Bruker Daltonics, Inc.
Microbiology · 240d