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
745–768 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators,...
K153375 · MRG
Abbott Laboratories
Chemistry · 263d
Cleared Aug 10, 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · JJX
Aalto Scientific, Ltd.
Chemistry · 33d
Cleared Aug 05, 2016
On Call Pro Blood Glucose Monitoring System
K161867 · NBW
Acon Laboratories
Chemistry · 29d
Cleared Jul 29, 2016
UniStrip1 Generic Blood Glucose Test Strips
K160038 · NBW
Ok Biotech Co., Ltd.
Chemistry · 204d
Cleared Jul 27, 2016
Tina-quant Cystatin C Gen.2
K161817 · NDY
Roche Diagnostics Operations (Rdo)
Chemistry · 26d
Cleared Jul 26, 2016
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur...
K160757 · CDD
Axis-Shield Diagnostics Limited
Chemistry · 130d
Cleared Jul 22, 2016
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K160372 · JIL
Teco Diagnostics, Inc.
Chemistry · 163d
Cleared Jul 20, 2016
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood...
K152599 · NBW
Ok Biotech Co., Ltd.
Chemistry · 313d
Cleared Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
K151978 · CHL
Edan Instruments, Inc.
Chemistry · 364d
Cleared Jul 08, 2016
i-STAT Alinity System with i-STAT Sodium test
K153357 · JGS
Abbott Point of Care, Inc.
Chemistry · 231d
Cleared Jun 29, 2016
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)...
K151986 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 348d
Cleared Jun 24, 2016
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next...
K160430 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 129d
Cleared Jun 24, 2016
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
K153692 · CGA
Infrared Laboratory Systems, LLC (Dba...
Chemistry · 184d
Cleared Jun 24, 2016
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor...
K153201 · NBW
Sd Biosensor
Chemistry · 233d
Cleared Jun 23, 2016
StatStrip Xpress Blood Glucose Monitoring System
K160156 · NBW
Nova Biomedical Corporation
Chemistry · 153d
Cleared Jun 09, 2016
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M...
K160370 · JGS
Shenzhen Mindray Bio-Medical...
Chemistry · 120d
Cleared Jun 01, 2016
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit,...
K153165 · PIG
Astute Medical, Inc.
Chemistry · 212d
Cleared May 31, 2016
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
K160647 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 85d
Cleared May 26, 2016
eSensor Warfarin Sensitivity Saliva Test
K152612 · ODW
Genmark Diagnostics, Incorporated
Chemistry · 255d
Cleared May 26, 2016
Oragene Dx
K152556 · OYJ
DNA Genotek, Inc.
Chemistry · 261d
Cleared May 26, 2016
ORAcollect.Dx
K152464 · OYJ
DNA Genotek, Inc.
Chemistry · 269d
Cleared May 25, 2016
Creatine Kinase
K160570 · JHS
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
K161140 · JIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared May 17, 2016
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone...
K161082 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 29d