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
625–648 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 19, 2019
Cepheid Xpert C. difficile/Epi Control Panel
K190463 · PMN
Microbiologics, Inc.
Microbiology · 52d
Cleared Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)...
K190109 · JWY
Beckman Coulter, Inc.
Microbiology · 85d
Cleared Apr 12, 2019
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K182619 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 200d
Cleared Mar 27, 2019
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K190302 · OZE
Centers For Disease Control and...
Microbiology · 43d
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · JWY
Liofilchem S. R. L.
Microbiology · 43d
Cleared Mar 19, 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · JWY
Liofilchem S. R. L.
Microbiology · 90d
Cleared Mar 18, 2019
ID NOW Influenza A & B 2
K190204 · OZE
Alere Scarborough, Inc.
Microbiology · 42d
Cleared CT Mar 18, 2019
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
K181599 · QFS
Beckman Coulter
Microbiology · 273d
Cleared Mar 14, 2019
Vstrip H. pylori Antigen Rapid Test
K183573 · LYR
Panion & BF Biotech, Inc.
Microbiology · 83d
Cleared Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
K183524 · LON
bioMerieux, Inc.
Microbiology · 83d
Cleared Mar 12, 2019
BioPlex 2200 Lyme Total
K183446 · LSR
Bio-Rad Laboratories
Microbiology · 90d
Cleared Mar 12, 2019
Endotoxin Activity Assay (EAA)
K183176 · NGS
Spectral Medical, Inc.
Microbiology · 116d
Cleared Mar 07, 2019
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
K183551 · LON
bioMerieux, Inc.
Microbiology · 77d
Cleared CT Mar 06, 2019
GenePOC Strep A
K183366 · PGX
Genepoc, Inc.
Microbiology · 92d
Cleared Feb 26, 2019
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
K183360 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
K183415 · LON
bioMerieux, Inc.
Microbiology · 72d
Cleared Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K183324 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 12, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam...
K183127 · LTT
Beckman Coulter, Inc.
Microbiology · 91d
Cleared Feb 11, 2019
BacT/ALERT FA Plus
K183166 · MDB
bioMerieux, Inc.
Microbiology · 88d
Cleared Feb 04, 2019
Capture-CMV
K183571 · LJO
Immucor, Inc.
Microbiology · 45d
Not Cleared Jan 23, 2019
Aptima Mycoplasma genitalium Assay
DEN180047 · QEP
Hologic, Inc.
Microbiology · 145d
Cleared Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
K183298 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · JWY
Biomerieux S.A.
Microbiology · 71d