FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
601–624 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 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
Cleared Jan 08, 2019
BD MAX CTGCTV2, BD MAX System
K182692 · OUY
Becton, Dickinson and Company
Microbiology · 103d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K183033 · JWY
Thermo Fisher Scientific
Microbiology · 64d
Cleared Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K182690 · PEO
Genmark Diagnostics, Incorporated
Microbiology · 85d
Cleared Dec 21, 2018
VITEK MS
K181412 · QBN
bioMerieux, Inc.
Microbiology · 205d
Cleared Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
K183115 · JWY
Liofilchem S. R. L.
Microbiology · 41d
Cleared Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663 · PAM
Genmark Diagnostics, Incorporated
Microbiology · 178d
Cleared Dec 19, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K183223 · OZZ
Diasorin Molecular, LLC
Microbiology · 29d
Cleared Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
K182001 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 144d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
K181766 · LON
bioMerieux, Inc.
Microbiology · 160d