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
481–504 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
K190326 · CDN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Feb 22, 2019
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use...
K181551 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 254d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183555 · JFY
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183549 · JGS
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183546 · CGA
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
Quo-Test A1c System
K180509 · LCP
Ekf Diagnostic GmbH
Chemistry · 354d
Cleared Feb 14, 2019
Dexcom G6 Continuous Glucose Monitoring System
K183206 · QBJ
Dexcom, Inc.
Chemistry · 87d
Not Cleared Feb 14, 2019
t:slim X2 insulin pump with interoperable technology
DEN180058 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 108d
Cleared Feb 13, 2019
Fenom Pro Nitric Oxide Test
K182874 · MXA
Spirosure, Inc.
Chemistry · 124d
Cleared Feb 12, 2019
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium...
K183375 · JJE
Horiba, Ltd.
Chemistry · 68d
Cleared Feb 08, 2019
Ammonia II
K183517 · JIF
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Jan 29, 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
K182521 · CDZ
Qualigen, Inc.
Chemistry · 138d
Cleared Jan 16, 2019
HbA1c Advanced
K182651 · PDJ
Beckman Coulter Ireland, Inc.
Chemistry · 114d
Cleared Jan 10, 2019
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette,...
K183097 · LCX
Weihai Kangzhou Biotechnology...
Chemistry · 64d
Cleared Dec 21, 2018
PTS Professional Chemistry Kit
K182781 · CGA
Polymer Technology Systems, Inc....
Chemistry · 81d
Cleared Dec 21, 2018
ADVIA Centaur Calcitonin (CALCT) assay
K182012 · JKR
Axis-Shield Diagnostics Limited
Chemistry · 147d
Not Cleared Dec 21, 2018
Miris Human Milk Analyzer
DEN180007 · QEI
Miris AB
Chemistry · 312d
Cleared Dec 19, 2018
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...
K173140 · NBW
Vivachek Laboratories, Inc.
Chemistry · 446d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593 · JIN
Apex BioTechnology Corp.
Chemistry · 89d
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d