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
601–624 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Not Cleared May 23, 2019
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin...
DEN180032 · QGN
Cd Diagnostics, Inc.
Microbiology · 328d
Cleared May 22, 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control...
K190433 · QEP
Roche Molecular Systems, Inc.
Microbiology · 89d
Cleared May 18, 2019
QIAstat-Dx Respiratory Panel
K183597 · OCC
QIAGEN GmbH
Microbiology · 148d
Cleared May 16, 2019
Aptima CV/TV Assay
K190472 · PQA
Hologic, Inc.
Microbiology · 79d
Cleared May 15, 2019
BACT/ALERT MP Reagent System
K190405 · MDB
bioMerieux, Inc.
Microbiology · 85d
Cleared May 15, 2019
APAS Independence with Urine Analysis Module
K183648 · PPU
Clever Culture Systems AG
Microbiology · 140d
Cleared May 13, 2019
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
K190219 · PLO
Diasorin Molecular, LLC
Microbiology · 98d
Cleared May 10, 2019
GenePOC Carba
K190275 · PMY
Genepoc, Inc.
Microbiology · 91d
Cleared May 08, 2019
Cepheid Xpert CT/NG Control Panel
K190223 · PMN
Microbiologics, Inc.
Microbiology · 92d
Cleared May 03, 2019
FilmArray Pneumonia/Pneumoniaplus Control
K190222 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154 · JWY
Biomerieux S.A.
Microbiology · 91d
Cleared Apr 29, 2019
HardyCHROM CRE
K190553 · JSO
Hardy Diagnostics
Microbiology · 55d
Cleared Apr 25, 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s...
K190771 · NQX
Cepheid
Microbiology · 30d
Cleared Apr 22, 2019
FluChip-8G Influenza A+B Assay
K182513 · OZE
Indevr, Inc.
Microbiology · 222d