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
697–720 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)...
K162538 · JIT
Siemens Healthcare Diagnostics
Chemistry · 66d
Cleared 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