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
601–624 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Oct 19, 2017
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · CFR
Abbott Laboratories
Chemistry · 260d
Cleared Oct 17, 2017
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare...
K160282 · NBW
Sd Biosensor
Chemistry · 623d
Cleared CT Oct 16, 2017
OptiScanner 5000 Glucose Monitoring System
K162042 · LZF
Optiscan Biomedical Corp.
Chemistry · 448d
Cleared Oct 13, 2017
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose...
K170241 · NBW
All Medicus Co., Ltd.
Chemistry · 260d