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
841–864 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 13, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx...
K162456 · OCC
Cepheid
Microbiology · 164d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · LON
bioMerieux, Inc.
Microbiology · 257d
Cleared Feb 09, 2017
cobas® CT/NG v2.0 Test
K163184 · LSL
Roche Molecular Systems, Inc.
Microbiology · 87d
Cleared Feb 09, 2017
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K162331 · OCC
Cepheid
Microbiology · 174d
Cleared Feb 09, 2017
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in...
K161810 · MDB
Becton Dickinson
Microbiology · 223d
Not Cleared Feb 06, 2017
Variola virus Real-Time PCR Assay
DEN160016 · PRA
Centers For Disease Control and...
Microbiology · 298d
Cleared Feb 01, 2017
Lyme B. burgdorferi (IgG) MarStripe Test
K163095 · LSR
Trinity Biotech
Microbiology · 89d
Cleared Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Jan 27, 2017
chromID Strepto B agar
K163042 · PQZ
bioMerieux, Inc.
Microbiology · 88d
Cleared Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K163006 · LON
bioMerieux, Inc.
Microbiology · 88d
Cleared Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
K161217 · LON
bioMerieux, Inc.
Microbiology · 258d
Cleared Jan 06, 2017
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162969 · LFZ
DiaSorin, Inc.
Microbiology · 74d
Cleared Jan 05, 2017
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
K162961 · LSE
DiaSorin, Inc.
Microbiology · 73d
Cleared Jan 04, 2017
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
K162959 · LSE
DiaSorin, Inc.
Microbiology · 72d
Cleared Dec 23, 2016
ARIES GBS Assay
K162772 · NJR
Luminex Corporation
Microbiology · 81d
Cleared Dec 21, 2016
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i...
K163266 · OCC
Alere Scarborough, Inc.
Microbiology · 30d
Cleared Dec 19, 2016
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
K162854 · JWY
Liofilchem S. R. L.
Microbiology · 68d
Cleared Dec 16, 2016
Chagas Detect Plus Rapid Test
K161947 · MIU
InBios International, Inc.
Microbiology · 155d
Cleared Nov 28, 2016
Solana HSV 1+2/VZV Assay
K162451 · PGI
Quidel Corporation
Microbiology · 88d
Cleared Nov 23, 2016
Xpert MRSA NxG
K162444 · NQX
Cepheid
Microbiology · 84d
Cleared Nov 15, 2016
HardyCHROM ESBL
K160512 · JSO
Hardy Diagnostics
Microbiology · 265d
Cleared Nov 04, 2016
Puritan Fecal Opti-Swab Collection and Transport System
K162284 · JSM
Puritan Medical Products, LLC
Microbiology · 81d
Cleared Oct 31, 2016
BreathID Hp Lab System
K162150 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 90d
Not Cleared Oct 28, 2016
BD MAX Vaginal Panel, BD MAX Instrument
DEN160001 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 291d