FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
577–600 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 27, 2018
ACE Hemoglobin A1c (HbA1c) Reagent
K170623 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 363d
Cleared Feb 16, 2018
DUS R-50S (Urine Chemistry system)
K171521 · JIL
DFI Co., Ltd.
Chemistry · 268d
Cleared Feb 07, 2018
CAPILLARYS Hb A1c
K171861 · PDJ
Sebia
Chemistry · 230d
Cleared Feb 02, 2018
ACRO HCG Pregnancy Rapid Test
K172512 · LCX
Acro Biotech, Inc.
Chemistry · 165d
Cleared Jan 25, 2018
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare...
K171971 · CJE
Lite-On Technology Corp. H.S.P.B.
Chemistry · 209d
Cleared Jan 19, 2018
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K171731 · OIF
Kronus, Inc.
Chemistry · 221d
Cleared Jan 17, 2018
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
K171247 · CDS
Epocal, Inc.
Chemistry · 264d
Cleared Jan 11, 2018
Diazyme EZ Vitamin D Assay
K172992 · MRG
Diazyme Laboratories
Chemistry · 106d
Cleared Dec 29, 2017
GEM Premier 5000
K173403 · CHL
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Dec 22, 2017
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early...
K172257 · JHI
True Diagnostics, Inc.
Chemistry · 149d
Cleared Dec 13, 2017
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose...
K171480 · NBW
I-Sens, Inc.
Chemistry · 208d
Cleared Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 173d
Cleared Nov 22, 2017
NIOX VERO
K170983 · MXA
Circassia AB
Chemistry · 233d
Cleared Nov 21, 2017
Alere Afinion HbA1c and ACR on Afinion 2 analyzer
K171650 · LCP
Abbott Rapid Diagnostics
Chemistry · 169d
Cleared Nov 20, 2017
LIA Pregnancy Test
K171136 · LCX
Lia Diagnostics
Chemistry · 217d
Cleared Nov 16, 2017
NEPHROCHECK Test System
K171482 · PIG
Astute Medical, Inc.
Chemistry · 181d
Cleared Nov 13, 2017
Access AMH
K170524 · PQO
Beckman Coulter, Inc.
Chemistry · 264d
Cleared Nov 07, 2017
StatStrip Xpress Blood Glucose Monitoring System
K170464 · NBW
Nova Biomedical Corporation
Chemistry · 265d
Cleared Nov 02, 2017
PixoTest Blood Glucose Monitoring System
K163087 · NBW
Ixensor Company , Ltd.
Chemistry · 364d
Cleared Oct 27, 2017
Abbott Architect Free T4
K173122 · CEC
Abbott Laboratories
Chemistry · 28d
Cleared Oct 27, 2017
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
K172133 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 105d
Cleared Oct 24, 2017
Alinity c ICT Sample Diluent
K170320 · CGZ
Abbott Laboratories
Chemistry · 265d
Cleared Oct 23, 2017
Alinity i Total ß-hCG Reagent Kit, Alinity i System
K170317 · DHA
Abbott Laboratories
Chemistry · 264d
Cleared Oct 19, 2017
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT...
K170614 · NBW
I-Sens, Inc.
Chemistry · 232d