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
769–792 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 14, 2016
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose...
K151487 · CFR
Diatron U.S., Inc.
Chemistry · 226d
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