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: Chemistry ×
13,234 results
505–528 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 10, 2018
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · JFY
Yd Diagnostics Corporation
Chemistry · 133d
Cleared Dec 10, 2018
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
K181675 · PTC
Taidoc Technology Corporation
Chemistry · 168d
Cleared Nov 30, 2018
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood...
K182046 · NBW
Tyson Bioresearch, Inc.
Chemistry · 122d
Cleared Nov 30, 2018
POPS! one Blood Glucose Monitoring System
K181588 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Nov 29, 2018
Afinion HbA1c Dx on Afinion 2
K182988 · PDJ
Alere Technologies AS
Chemistry · 31d
Cleared Nov 29, 2018
Tyson Bio HT100-A Blood Glucose Monitoring System
K182047 · NBW
Tyson Bioresearch, Inc.
Chemistry · 121d
Cleared Nov 28, 2018
BGM014 Blood Glucose Monitoring System
K182992 · NBW
Apex BioTechnology Corp.
Chemistry · 30d
Cleared Nov 02, 2018
Dexcom Pro Q Continuous Glucose Monitoring System
K182405 · QDL
Dexcom, Inc.
Chemistry · 59d
Cleared Nov 01, 2018
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine...
K181273 · NBW
I-Sens, Inc.
Chemistry · 171d
Not Cleared Oct 31, 2018
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
DEN180028 · QDJ
23AndMe, Inc.
Chemistry · 148d
Cleared Oct 30, 2018
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides,...
K182072 · CGZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 30, 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides,...
K182063 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 26, 2018
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K182041 · QDK
Dexcom, Inc.
Chemistry · 88d
Cleared Oct 23, 2018
Randox Calcium (Ca)
K182042 · CJY
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Oct 18, 2018
Extended Lipid Panel Assay
K181373 · CHH
Laboratory Corporation of America...
Chemistry · 147d
Cleared Oct 12, 2018
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · DCN
The Binding Site Group , Ltd.
Chemistry · 269d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423 · CEC
Shenzhen New Industries Biomedical...
Chemistry · 28d
Cleared Oct 04, 2018
Diazyme 1,5-AG Assay
K180209 · NOZ
Diazyme Laboratories, Inc.
Chemistry · 253d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Sep 27, 2018
CRP Vario
K173833 · NQD
SENTINEL CH. SpA
Chemistry · 283d
Cleared Sep 26, 2018
Stat Profile Prime Plus Analyzer System
K180340 · CGA
Nova Biomedical Corporation
Chemistry · 231d
Cleared Sep 25, 2018
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1...
K173127 · LCP
Skyla Corporation H.S.P.B
Chemistry · 361d
Cleared Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 27d
Cleared Sep 18, 2018
Elecsys FT4 III
K181233 · CEC
Roche Diagnostics
Chemistry · 132d