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
889–912 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145 · LIP
Fujirebio Diagnostics,Inc.
Microbiology · 249d
Cleared Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A...
K161556 · OZE
Centers For Disease Control and...
Microbiology · 24d
Cleared Jun 30, 2016
LIAISON CMV IgM Serum Control Set
K161526 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
LIAISON EBV IgM Serum Control Set
K161522 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...
K161495 · OOI
Luminex Corporation
Microbiology · 29d
Cleared Jun 29, 2016
Xpert Carba-R
K160901 · POC
Cepheid
Microbiology · 89d
Cleared Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
K160911 · PMT
bioMerieux, Inc.
Microbiology · 88d
Cleared Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · JWY
Liofilchem S. R. L.
Microbiology · 190d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...
K153730 · LIP
Abbott Laboratories
Microbiology · 170d
Cleared CT Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma...
K160829 · OZX
Meridian Bioscience, Inc.
Microbiology · 80d
Cleared Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
K160729 · PMT
Roche Diagnostics
Microbiology · 89d
Cleared May 13, 2016
SeraQuest HSV Type 2 Specific IgG
K152353 · MYF
Quest International, Inc.
Microbiology · 267d
Cleared May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek...
K152679 · PMN
Bio-Rad Laboratories
Microbiology · 235d
Cleared Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075 · LON
bioMerieux, Inc.
Microbiology · 263d
Cleared Apr 12, 2016
ARIES System
K160517 · OOI
Luminex Corporation
Microbiology · 48d
Cleared Apr 01, 2016
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
K160459 · PCH
Biofire Diagnostics, LLC
Microbiology · 42d
Cleared Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · JWY
Liofilchem S. R. L.
Microbiology · 99d
Not Cleared Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...
DEN150058 · PMN
Bio-Rad Laboratories
Microbiology · 103d
Cleared Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
K152470 · PAM
Great Basin Scientific, Inc.
Microbiology · 207d
Cleared Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
K151923 · NGZ
bioMerieux, Inc.
Microbiology · 256d
Cleared Mar 22, 2016
Great Basin Shiga Toxin Direct Test
K152955 · PCH
Great Basin Scientific, Inc.
Microbiology · 167d
Cleared Mar 17, 2016
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
K160462 · PLO
Biofire Diagnostics, LLC
Microbiology · 27d
Cleared Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · PEN
Biofire Diagnostics, LLC
Microbiology · 25d
Cleared Mar 14, 2016
ImmunoCard STAT! HpSA
K153661 · LYR
Meridian Bioscience, Inc.
Microbiology · 84d