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
577–600 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 01, 2019
Applied Biosystems Bacillus anthracis Detection Kit
K183462 · QIF
Mriglobal
Microbiology · 291d
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050 · JWY
Biomerieux S.A.
Microbiology · 58d
Cleared Sep 25, 2019
ARIES MRSA Assay
K191742 · NQX
Luminex Corporation
Microbiology · 86d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · JTN
Hardy Diagnostics
Microbiology · 23d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · JWY
Liofilchem S. R. L.
Microbiology · 50d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · POC
Check-Points Health B.V.
Microbiology · 171d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · JWY
Liofilchem S. R. L.
Microbiology · 49d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · JWY
Biomerieux S.A.
Microbiology · 31d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · LOL
Roche Diagnostics
Microbiology · 172d
Cleared CT Aug 08, 2019
binx health io CT/NG Assay
K191352 · QEP
Binx Health, Inc.
Microbiology · 80d
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · JTN
Hardy Diagnostics
Microbiology · 12d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398 · LSR
Zeus Scientific, Inc.
Microbiology · 66d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191240 · LSR
Zeus Scientific, Inc.
Microbiology · 82d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K190907 · LSR
Zeus Scientific, Inc.
Microbiology · 112d
Cleared Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729 · OCC
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur...
K191578 · QFO
Siemens Healthcare Diagnostics, Inc.
Microbiology · 33d
Cleared Jul 17, 2019
Fungitell STAT
K191167 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 77d
Cleared Jul 11, 2019
ID NOW Influenza A & B 2
K191534 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 31d
Cleared Jul 01, 2019
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
K190905 · LON
Becton, Dickinson and Company
Microbiology · 84d
Cleared Jun 28, 2019
iC-GN iC-Cassette for use on the iC-System
K190341 · PEN
Icubate, Inc.
Microbiology · 134d
Cleared Jun 25, 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · PMN
Microbiologics, Inc.
Microbiology · 55d
Cleared Jun 20, 2019
Campylobacter Quik Chek
K191456 · LQP
Techlab, Inc.
Microbiology · 20d
Cleared Jun 20, 2019
Campylobacter Chek
K191442 · LQP
Techlab, Inc.
Microbiology · 21d