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
697–720 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 12, 2017
Lumipulse G Prolactin
K163544 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 27d
Cleared Jan 12, 2017
Lumipulse G LH Calibrators
K163521 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 12, 2017
FREND Vitamin D Test System
K162754 · MRG
Nanoentek USA, Inc.
Chemistry · 104d
Cleared Jan 12, 2017
Contour Next EZ Blood Glucose Monitoring System
K162336 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 143d
Cleared Jan 06, 2017
StatStrip Xpress 2 Glucose Hospital Meter System
K163490 · PZI
Nova Biomedical Corporation
Chemistry · 25d
Cleared Dec 23, 2016
Kurin Blood Culture Collection Set
K162233 · JKA
Pathway, LLC
Chemistry · 137d
Cleared Dec 23, 2016
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring...
K161299 · NBW
Apex BioTechnology Corp.
Chemistry · 228d
Cleared Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System
K162282 · CGA
Polymer Technology Systems, Inc....
Chemistry · 129d
Cleared Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test...
K151545 · CHH
Polymer Technology Systems, Inc.
Chemistry · 562d
Cleared Dec 19, 2016
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
K160571 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 294d
Not Cleared Dec 19, 2016
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
DEN150057 · PQO
Roche Diagnostics
Chemistry · 376d
Cleared Dec 16, 2016
VITROS Chemistry Products Cl- Slides
K162020 · CGZ
Ortho-Clinical Diagnostics
Chemistry · 148d
Cleared Dec 16, 2016
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
K161837 · JGS
Beckman Coulter, Inc.
Chemistry · 164d
Cleared Dec 16, 2016
NoCoding1 Plus Blood Glucose Monitoring System
K160742 · NBW
I-Sens, Inc.
Chemistry · 274d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin,...
K160415 · GKF
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412 · CHL
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · CGA
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized...
K160225 · JGS
Instrumentation Laboratory CO
Chemistry · 320d
Cleared Dec 08, 2016
DC-UIBC-CAL
K163078 · JIT
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 35d
Cleared Dec 01, 2016
Lumipulse G E2-III Calibrators
K163053 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 30d
Cleared Dec 01, 2016
EasyLyte Na/K/Cl/Ca Analyzer
K152327 · JFP
Medica Corporation
Chemistry · 471d
Cleared Nov 30, 2016
One Drop Blood Glucose Monitoring System
K161834 · NBW
Agamatrix, Inc.
Chemistry · 148d
Cleared Nov 21, 2016
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c...
K160762 · LCP
Diazyme Laboratories
Chemistry · 245d
Cleared Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)...
K162538 · JIT
Siemens Healthcare Diagnostics
Chemistry · 66d