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: Chemistry ×
13,257 results
529–552 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Sep 12, 2018
Magnesium
K181748 · JGJ
Abbott Laboratories
Chemistry · 72d