FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
265–288 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329 · LSL
Hologic, Inc.
Microbiology · 263d
Cleared Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
K231187 · QVF
Nano-Ditech Corporation
Microbiology · 272d
Cleared Dec 27, 2023
Colibrí
K232756 · LON
Copan Wasp Srl
Microbiology · 110d
Cleared Dec 22, 2023
NeuMoDx CT/NG Assay 2.0
K230267 · QEP
Neumodx Molecular, Inc.
Microbiology · 325d
Cleared Dec 21, 2023
KaiBiLi Extended ViralTrans
K231027 · JSM
Hangzhou Genesis Biodetection &...
Microbiology · 254d
Cleared Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286 · PGI
Quidel Corporation
Microbiology · 141d
Cleared Dec 15, 2023
Hp Detect™ Stool Antigen ELISA
K232892 · LYR
Biomerica, Inc.
Microbiology · 88d
Cleared Dec 15, 2023
SeptiCyte RAPID
K232095 · PRE
Immunexpress, Inc.
Microbiology · 155d
Cleared Dec 13, 2023
Sofia 2 SARS Antigen+ FIA
K233688 · QVF
Quidel Corporation
Microbiology · 26d
Cleared Dec 05, 2023
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
K232434 · PSZ
Bd
Microbiology · 116d
Cleared Dec 04, 2023
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K223783 · QWR
Roche Molecular Systems, Inc.
Microbiology · 353d
Cleared Nov 28, 2023
Cue COVID-19 Molecular Test
K232643 · QWB
Cue Health, Inc.
Microbiology · 90d
Cleared Nov 20, 2023
The SensiTox B. anthracis Toxin Test
K232545 · QUU
First Light Diagnostics, Inc.
Microbiology · 90d
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451 · MKZ
Hologic, Inc.
Microbiology · 268d
Not Cleared Nov 15, 2023
Simple 2 Test
DEN200070 · QYA
Letsgetchecked Inc. (Formerly...
Microbiology · 1094d
Cleared Nov 14, 2023
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · OZN
Vela Operations USA
Microbiology · 124d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828 · QYT
ACON Laboratories, Inc.
Microbiology · 227d
Cleared Nov 06, 2023
Aptima Trichomonas vaginalis Assay
K231316 · OUY
Hologic, Inc.
Microbiology · 182d
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · LFY
DiaSorin, Inc.
Microbiology · 182d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...
K232201 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 19, 2023
Xpert Xpress MVP
K231381 · PQA
Cepheid
Microbiology · 160d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · QQX
Cepheid
Microbiology · 234d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 29d