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
793–816 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 08, 2016
Direct HDL Cholesterol (HDL)
K153435 · LBS
Randox Laboratories, Ltd.
Chemistry · 42d
Cleared Jan 08, 2016
ONLINE TDM Vancomycin Gen.3
K152245 · LEH
Roche Diagnostics Operations (Rdo)
Chemistry · 151d
Cleared Jan 08, 2016
MyGlucoHealth Wireless System
K143169 · NBW
Entra Health Systems
Chemistry · 430d
Cleared Jan 07, 2016
TIVA¿
K152924 · JKA
Velano Vascular
Chemistry · 94d
Cleared Dec 21, 2015
Dario Blood Glucose Monitoring System
K150817 · NBW
Labstyle Innovations, Ltd.
Chemistry · 269d
Cleared Dec 18, 2015
ST AIA-PACK PROG III Calibrator Set
K153417 · JIT
Tosoh Bioscience, Inc.
Chemistry · 23d
Cleared Dec 18, 2015
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
K153365 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
K152155 · CDZ
Abbott Laboratories
Chemistry · 136d
Cleared Dec 17, 2015
PRODIGY iConnect Blood Glucose Monitoring System
K142785 · NBW
Ok Biotech Co., Ltd.
Chemistry · 447d
Cleared Dec 14, 2015
OneTouch Ultra Plus Flex Blood Glucose Monitoring System
K151611 · NBW
Lifescan Europe
Chemistry · 182d
Cleared Dec 11, 2015
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT...
K151767 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 164d
Cleared Dec 11, 2015
Liquichek Cardiac Markers Plus Control LT
K150300 · JJY
Bio-Rad Laboratories
Chemistry · 308d
Cleared Dec 09, 2015
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 205d
Cleared Dec 07, 2015
ABL80 FLEX and ABL80 FLEX CO-OX
K151639 · CGA
Sendx Medical, Inc.
Chemistry · 172d
Cleared Dec 04, 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart...
K150833 · NBW
Andon Health Co, Ltd.
Chemistry · 249d
Cleared Dec 01, 2015
Gmate Origin Blood Glucose Monitoring System
K151658 · NBW
Philosys, Inc.
Chemistry · 165d
Cleared Nov 25, 2015
Contour Next USB Blood Glucose Monitoring System
K150942 · NBW
Bayer Healthcare
Chemistry · 231d
Cleared Nov 25, 2015
Cortisol Saliva Luminescence Immunoassay
K150528 · NHG
Ibl International GmbH
Chemistry · 268d
Cleared Nov 24, 2015
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose...
K151265 · NBW
Sd Biosensor
Chemistry · 195d
Cleared Nov 20, 2015
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH...
K151792 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 142d
Cleared Nov 19, 2015
Gmate SMART Blood Glucose Monitoring System
K150299 · NBW
Philosys, Inc.
Chemistry · 286d
Cleared Oct 26, 2015
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set,...
K150270 · MRG
Tosoh Bioscience, Inc.
Chemistry · 264d
Cleared Oct 14, 2015
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro...
K150396 · NBW
Apex BioTechnology Corp.
Chemistry · 238d