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
1177–1200 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 18, 2012
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
K120911 · OQW
Cepheid
Microbiology · 53d
Cleared May 15, 2012
FILMARRAY RP PANEL
K120267 · OCC
Idaho Technology, Inc.
Microbiology · 106d
Cleared May 03, 2012
APTIMA COMBO 2 ASSAY
K111409 · LSL
Gen-Probe, Inc.
Microbiology · 350d
Cleared May 01, 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · NJR
Meridian Bioscience, Inc.
Microbiology · 25d
Not Cleared Apr 30, 2012
PORTRAIT ANALYZER
DEN120013 · OMN
Great Basin Scientific
Microbiology · 59d
Cleared Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
K113847 · LSR
Gold Standard Diagnostics
Microbiology · 104d
Cleared Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433 · OMN
Focus Diagnostics, Inc.
Microbiology · 135d
Cleared Apr 03, 2012
STAPHYLOCOCCUS QUICKFISH BC
K113371 · NXX
Advandx, Inc.
Microbiology · 139d
Cleared Mar 30, 2012
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
K120563 · OUS
Microphage, Inc.
Microbiology · 35d
Cleared Mar 28, 2012
CRAG LATERAL FLOW ASSAY (LFA)
K112422 · GMD
Immuno-Mycologics, Inc.
Microbiology · 218d
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 28d
Cleared Mar 23, 2012
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K120049 · PSZ
Becton, Dickinson and Company
Microbiology · 77d
Cleared Mar 16, 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558 · MDB
Becton, Dickinson and Company
Microbiology · 106d
Cleared Mar 15, 2012
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · OZE
Quidel Corp.
Microbiology · 85d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · LIP
Bio-Rad Laboratories, Inc.
Microbiology · 30d
Cleared Mar 02, 2012
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745 · LYR
Gold Standard Diagnostics
Microbiology · 351d
Cleared Mar 01, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K113249 · JSM
Puritan Medical Products, LLC
Microbiology · 119d
Cleared Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · LON
bioMerieux, Inc.
Microbiology · 238d
Cleared Feb 24, 2012
TRU LEGIONELLA
K113190 · MJH
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · LON
bioMerieux, Inc.
Microbiology · 220d
Cleared Feb 17, 2012
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
K112781 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 144d
Cleared Feb 16, 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · NJR
Becton, Dickinson & CO
Microbiology · 231d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 06, 2012
ROTOR-GENE Q MDX
K113319 · OOI
QIAGEN GmbH
Microbiology · 88d