FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
721–744 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 19, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K171552 · OCC
Cepheid
Microbiology · 207d
Cleared Dec 15, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam...
K172337 · LTT
Beckman Coulter, Inc.
Microbiology · 135d
Cleared Dec 13, 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza...
K173502 · PSZ
Alere Scarborough, Inc.
Microbiology · 30d
Cleared Dec 12, 2017
T2Candida 1.1 Panel
K173536 · PII
T2biosystems, Inc.
Microbiology · 27d
Cleared Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722 · LSR
Euroimmun Us, Inc.
Microbiology · 90d
Cleared Dec 10, 2017
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G...
K172713 · PRI
Fujirebio Diagnostics,Inc.
Microbiology · 93d
Cleared Dec 08, 2017
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
K172731 · LON
bioMerieux, Inc.
Microbiology · 88d
Cleared Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 –...
K172912 · LTT
Beckman Coulter, Inc.
Microbiology · 73d
Cleared Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
K172629 · OCC
Hologic, Inc.
Microbiology · 94d
Cleared Dec 01, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K173209 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam...
K172255 · LTT
Beckman Coulter, Inc.
Microbiology · 128d
Not Cleared Nov 29, 2017
GeneSTAT.MDx Coccidioides Assay
DEN170041 · QAA
Dxna, LLC
Microbiology · 120d
Cleared Nov 24, 2017
FilmArray RP2/RP2plus Control Panel
K173171 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 56d
Not Cleared Nov 24, 2017
FilmArray Respiratory Panel 2 plus (RP2plus)
DEN170017 · PZF
Biofire Diagnostics, LLC
Microbiology · 253d
Cleared Nov 22, 2017
GenePOC CDiff
K172569 · OZN
Genepoc, Inc.
Microbiology · 89d
Cleared Oct 30, 2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
K172402 · PGX
Luminex Corporation
Microbiology · 82d
Cleared Oct 23, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
K172542 · JWY
Liofilchem S. R. L.
Microbiology · 61d
Cleared Oct 23, 2017
Panther Fusion Paraflu Assay
K172282 · OOU
Hologic, Inc.
Microbiology · 87d
Cleared Oct 23, 2017
Lyme B. burgdorferi (IgM) MarStripe Test
K172254 · LSR
Trinity Biotech
Microbiology · 89d
Cleared Oct 20, 2017
Sofia Lyme FIA, Sofia Lyme Control Set
K163713 · LSR
Quidel Corporation
Microbiology · 294d
Cleared Oct 16, 2017
Solana RSV+hMPV Assay
K171974 · OCC
Quidel Corporation
Microbiology · 108d
Cleared Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K172454 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Sep 29, 2017
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B...
K171792 · OCC
Alere Scarborough, Inc.
Microbiology · 105d