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
721–744 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared CT Nov 17, 2016
CONTOUR NEXT ONE Blood Glucose Monitoring System
K160682 · NBW
Ascensia Diabetes Care
Chemistry · 252d
Cleared Nov 15, 2016
StatStrip Xpress Glucose Hospital Meter System
K161856 · PZI
Nova Biomedical Corporation
Chemistry · 132d
Cleared Nov 15, 2016
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
K161831 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 133d
Cleared Nov 15, 2016
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 167d
Cleared Nov 10, 2016
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone...
K161738 · NBW
Taidoc Technology Corporation
Chemistry · 140d
Cleared Nov 04, 2016
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
K161646 · CGN
Diazyme Laboratories
Chemistry · 142d
Cleared Nov 04, 2016
ABL90 FLEX PLUS
K160153 · CHL
Radiometer Medical Aps
Chemistry · 287d
Cleared Oct 26, 2016
Multichem A1c
K162514 · JJX
Technopath Manufacturing
Chemistry · 48d
Cleared Oct 21, 2016
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH...
K160541 · JLW
Sysmex America, Inc.
Chemistry · 238d
Cleared Oct 19, 2016
HDL-Cholesterol Gen.4
K162593 · LBS
Roche Diagnostics Operations (Rdo)
Chemistry · 33d
Cleared Oct 18, 2016
VITROS® Automation Solutions
K160495 · KLI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 239d
Cleared Oct 14, 2016
D-10 Hemoglobin A1c Program
K161687 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 119d
Cleared Oct 14, 2016
FREND Testosterone Test System
K153577 · CDZ
Nanoentek USA, Inc.
Chemistry · 304d
Cleared Oct 07, 2016
AUTION ELEVEN Semi-Automated Urinalysis System
K160062 · JIL
Arkray, Inc.
Chemistry · 269d
Cleared Sep 28, 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood...
K160365 · NBW
Infopia Co, Ltd.
Chemistry · 232d
Cleared Sep 23, 2016
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
K160657 · JKA
Becton, Dickinson and Company
Chemistry · 199d
Cleared Sep 20, 2016
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme...
K161721 · CDD
Diazyme Laboratories
Chemistry · 90d
Cleared Sep 14, 2016
GEM Premier 3000
K161818 · CGA
Instrumentation Laboratory CO
Chemistry · 75d
Cleared Sep 07, 2016
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3...
K160724 · CGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Sep 07, 2016
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2,...
K153644 · CFR
Elitechgroup
Chemistry · 261d
Cleared Aug 31, 2016
ACCU-CHEK Guide Blood Glucose Monitoring System
K160944 · NBW
Roche Diabetes Care, Inc.
Chemistry · 148d
Cleared Aug 19, 2016
iHealth Align Gluco-Monitoring system
K153286 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 19, 2016
Wireless Smart Gluco-Monitoring System
K153278 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access...
K153651 · JLW
Beckman Coulter, Inc.
Chemistry · 241d