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
673–696 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 13, 2017
Lumipulse G FSH-N Calibrators
K163534 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
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