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
577–600 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Feb 02, 2018
ACRO HCG Pregnancy Rapid Test
K172512 · LCX
Acro Biotech, Inc.
Chemistry · 165d