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
1–24 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 30, 2026
eplex RP3 Control M530
K263232 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 44d
Cleared Oct 30, 2026
Xpert® Hemorrhagic Fever Panel
K262971 · QVR
Cepheid
Microbiology · 65d
Cleared Oct 30, 2026
cobas eplex respiratory pathogen panel 3
K262938 · QOF
GenMark Diagnostics, Inc.
Microbiology · 70d
Cleared Oct 27, 2026
BD Veritor System for SARS-CoV-2
K261379 · QVF
BD Diagnostic Solutions / Becton,...
Microbiology · 183d
Cleared Oct 23, 2026
B·R·A·H·M·S MR-proADM KRYPTOR
K260302 · SJQ
B·R·A·H·M·S GmbH (part of Thermo...
Microbiology · 266d
Cleared Oct 22, 2026
Xpert Xpress CoV-2/Flu plus
K263333 · QOF
Cepheid
Microbiology · 30d
Cleared Oct 21, 2026
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
K262573 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 86d
Cleared Oct 21, 2026
BIOFIRE SPOTFIRE Vaginitis (VG) Panel
K262136 · PQA
Biofire Diagnostics, LLC
Microbiology · 118d
Cleared Oct 21, 2026
DASH Flu A/B Test
K261347 · OCC
Nuclein, LLC
Microbiology · 180d
Not Cleared Oct 20, 2026
Elecsys HBsAg II quant II RxDx
DEN260027 · SJM
Roche Diagnostics
Microbiology · 140d
Cleared Oct 19, 2026
Access MeMed BV
K261109 · QPS
Beckman Coulter, Inc.
Microbiology · 199d
Cleared Oct 14, 2026
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test
K262432 · SCA
CorDx, Inc.
Microbiology · 90d
Cleared Oct 07, 2026
B. anthracis Real-time PCR Assay
K262368 · NHT
Centers For Disease Control and...
Microbiology · 89d
Cleared Oct 02, 2026
Xpert Xpress CoV-2/Flu plus
K263120 · QOF
Cepheid
Microbiology · 28d
Cleared Oct 02, 2026
Elecsys EBV IgM
K260233 · LJN
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV VCA IgG
K260232 · LSE
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV EBNA IgG
K260221 · LSE
Roche Diagnostics
Microbiology · 249d
Cleared Oct 01, 2026
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
K260283 · LON
bioMerieux, Inc.
Microbiology · 245d
Cleared Sep 30, 2026
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes...
K263035 · OZE
Centers For Disease Control and...
Microbiology · 30d
Cleared Sep 28, 2026
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
K260619 · LON
Biom?rieux, Inc.
Microbiology · 215d
Cleared Sep 25, 2026
Xpert Respiratory Panel
K261336 · QOF
Cepheid
Microbiology · 155d
Cleared Sep 24, 2026
QIAstat-Dx BCID GN Plus AMR Panel
K262168 · PEN
QIAGEN GmbH
Microbiology · 90d
Cleared Sep 23, 2026
Anti-HCV Next
K262156 · MZO
Abbott Laboratories
Microbiology · 89d
Cleared Sep 22, 2026
BIOFIRE Respiratory Panel 2.1 (RP2.1)
K263054 · QOF
Biofire Diagnostics
Microbiology · 21d