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
553–576 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 12, 2018
Access hs Tnl
K172783 · MMI
Beckman Coulter, Inc.
Chemistry · 270d
Not Cleared Jun 12, 2018
DreaMed Advisor Pro
DEN170043 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 299d
Cleared May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · NDY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 31d
Cleared May 25, 2018
inui In-Home Urine Analysis Test System
K180356 · JIL
Scanadu, Inc.
Chemistry · 106d
Cleared May 23, 2018
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024 · JIL
DFI Co., Ltd.
Chemistry · 35d
Cleared May 18, 2018
Acro HCG Pregnancy Rapid Test
K180771 · LCX
Acro Biotech, Inc.
Chemistry · 56d
Cleared May 18, 2018
Magnesium
K173294 · JGJ
Abbott Laboratories
Chemistry · 214d
Cleared May 07, 2018
Afinion HbA1c Dx
K180296 · PDJ
Alere Technologies AS
Chemistry · 94d
Cleared May 04, 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345 · JIN
Taidoc Technology Corporation
Chemistry · 192d
Cleared Apr 13, 2018
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
K170901 · CIX
Biosystems S.A.
Chemistry · 382d
Cleared Apr 13, 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone...
K170463 · JIN
I-Sens, Inc.
Chemistry · 422d
Cleared Apr 12, 2018
Atellica IM Folate Assay
K172201 · CGN
Siemens Healthcare Diagnostics, Inc.
Chemistry · 265d
Cleared Mar 29, 2018
Atellica IM Total hCG (ThCG)
K172322 · JHI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 240d
Cleared Mar 28, 2018
Mission Lipid Panel Monitoring System
K180504 · CHH
ACON Laboratories, Inc.
Chemistry · 30d
Cleared Mar 28, 2018
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 208d
Not Cleared Mar 27, 2018
Dexcom G6 Continuous Glucose Monitoring System
DEN170088 · QBJ
Dexcom, Inc.
Chemistry · 109d
Cleared Mar 23, 2018
Dario LC Blood Glucose Monitoring System
K172723 · NBW
Labstyle Innovation, Ltd.
Chemistry · 193d
Cleared Mar 22, 2018
Diazyme Lipoprotein (a) Assay
K180074 · DFC
Diazyme Laboratories, Inc.
Chemistry · 71d
Cleared Mar 12, 2018
Preview Digital Pregnancy Test
K173229 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 159d
Cleared Mar 07, 2018
On Call Express Mobile Blood Glucose Monitoring System
K180196 · NBW
ACON Laboratories, Inc.
Chemistry · 42d
Cleared Feb 27, 2018
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
K171476 · JGS
Awareness Technology, Inc.
Chemistry · 284d
Cleared Feb 27, 2018
ACE Hemoglobin A1c (HbA1c) Reagent
K170623 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 363d
Cleared Feb 16, 2018
DUS R-50S (Urine Chemistry system)
K171521 · JIL
DFI Co., Ltd.
Chemistry · 268d
Cleared Feb 07, 2018
CAPILLARYS Hb A1c
K171861 · PDJ
Sebia
Chemistry · 230d