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
553–576 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jun 20, 2019
Cepheid Xpert MRSA NxG Control Panel
K191172 · PMN
Microbiologics, Inc.
Microbiology · 50d
Cleared Jun 19, 2019
EntericBio Dx Assay
K182703 · PCH
Serosep , Ltd.
Microbiology · 265d
Cleared Jun 13, 2019
SeraQuest HSV Type 2 Specific IgG
K181514 · MYF
Quest International, Inc.
Microbiology · 370d
Cleared Jun 06, 2019
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
K190616 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Jun 05, 2019
Biocode Gastrointestinal Pathogen Panel (GPP)
K190585 · PCH
Applied BioCode, Inc.
Microbiology · 91d
Cleared May 29, 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914 · JWY
Liofilchem S. R. L.
Microbiology · 51d
Cleared May 23, 2019
Aptima Combo 2 Assay (Panther System)
K190515 · QEP
Hologic, Inc.
Microbiology · 83d
Cleared May 23, 2019
Aptima BV Assay
K190452 · PQA
Hologic, Inc.
Microbiology · 87d
Cleared May 23, 2019
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert...
K190441 · QEP
Cepheid
Microbiology · 87d
Not Cleared May 23, 2019
ZIKV Detect 2.0 IgM Capture ELISA
DEN180069 · QFO
InBios International, Inc.
Microbiology · 148d