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
745–768 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 21, 2017
Solana GBS Assay
K173250 · NJR
Quidel Corporation
Microbiology · 72d
Cleared Dec 21, 2017
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · GTY
Quidel Corporation
Microbiology · 174d
Cleared Dec 19, 2017
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
K173307 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
K172944 · LON
bioMerieux, Inc.
Microbiology · 84d
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 CT 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