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
1033–1056 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared May 02, 2014
FILMARRAY GASTROINTESTINAL (GI) PANEL
K140407 · PCH
Biofire Diagnostics
Microbiology · 73d
Cleared Apr 25, 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME...
K140857 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Apr 25, 2014
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR...
K140851 · OEP
Centers For Disease Control and...
Microbiology · 22d
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