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
1153–1176 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Feb 06, 2012
ARTUS INFL A/B RG RT-PCR KIT
K113323 · OCC
QIAGEN GmbH
Microbiology · 88d
Cleared Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · LYR
Gold Standard Diagnostics
Microbiology · 308d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 298d
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · LIP
Siemens Healthcare Diagnostics, Inc.
Microbiology · 158d