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
649–672 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 10, 2017
i-Stat Alinity System with i-Stat Glucose test
K163271 · CGA
Abbott Point of Care, Inc.
Chemistry · 140d
Cleared Apr 06, 2017
POGO Automatic Blood Glucose Monitoring System
K162203 · NBW
Intuity Medical, Inc.
Chemistry · 244d
Cleared Apr 04, 2017
Beta-CrossLaps CalCheck 5
K170678 · JJX
Roche Diagnostics
Chemistry · 29d
Cleared Mar 31, 2017
Multichem IA Plus
K162530 · JJY
Techno-Path Manufacturing
Chemistry · 203d
Cleared Mar 21, 2017
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood...
K152534 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 564d
Cleared Mar 20, 2017
Direct LDL Cholesterol (LDL)
K161691 · MRR
Randox Laboratories Limited
Chemistry · 273d
Cleared Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG
Siemens Healthcare Diagnostics
Chemistry · 212d
Cleared Mar 09, 2017
BGM009 Plus Blood Glucose Monitoring System
K170267 · NBW
Apex BioTechnology Corp.
Chemistry · 41d
Cleared Mar 09, 2017
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
K170065 · JFM
Siemens Healthcare Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-,...
K161954 · JGS
Siemens Healthcare Diagnostics
Chemistry · 234d
Cleared Feb 17, 2017
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
K162281 · LCP
Sebia
Chemistry · 186d
Cleared Feb 16, 2017
TAP Blood Collection Device
K161521 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 259d
Cleared Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
K153561 · NBW
Andon Health Co, Ltd.
Chemistry · 430d
Cleared Feb 15, 2017
Abbott ARCHITECT Free T3
K170160 · JIT
Abbott Laboratories
Chemistry · 28d
Cleared Feb 09, 2017
UA-Cellular Complete
K170091 · JJW
Streck
Chemistry · 30d
Cleared Feb 09, 2017
PIVO
K163508 · JKA
Velano Vascular
Chemistry · 57d
Cleared Feb 08, 2017
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D...
K162840 · MRG
Roche Diagnostics
Chemistry · 120d
Not Cleared Feb 03, 2017
SEEKER System
DEN150035 · PQW
Baebies, Inc.
Chemistry · 548d
Cleared Jan 31, 2017
IDS-iSYS Intact PTHN
K161158 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 281d
Cleared Jan 23, 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
K162606 · JLW
Roche Diagnostics
Chemistry · 126d
Cleared Jan 19, 2017
UniStrip1 Generic Blood Glucose Test Strips
K162430 · NBW
Ok Biotech Co., Ltd.
Chemistry · 141d
Cleared Jan 19, 2017
Atellica CH Magnesium (Mg)
K162399 · JGJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 146d
Cleared Jan 18, 2017
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet,...
K162895 · MMI
Roche Diagnostics
Chemistry · 93d
Cleared Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
K163546 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d