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
649–672 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 06, 2017
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System...
K170143 · NBW
Bionime Corporation
Chemistry · 170d
Cleared Jun 29, 2017
ADAMS A1c HA-8180V, CALIBRATOR 80
K162822 · PDJ
Arkray Factory, Inc.
Chemistry · 265d
Cleared Jun 22, 2017
Ion PGM Dx System
K170299 · PFF
Life Technologies Corporation
Chemistry · 142d
Cleared Jun 16, 2017
A1C EZ Glycohemoglobin Analysis System
K161533 · LCP
Biohermes Co., Ltd.
Chemistry · 379d
Cleared Jun 07, 2017
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose...
K162564 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 266d
Cleared Jun 01, 2017
Carbon Dioxide Reagent Set
K170200 · KHS
Teco Diagnostics, Inc.
Chemistry · 129d
Cleared May 26, 2017
Nova StatSensor Creatinine Hospital Meter System
K171059 · CGL
Nova Biomedical Corporation
Chemistry · 46d
Cleared May 26, 2017
Creatine Kinase-MB
K162526 · JHW
Roche Diagnostics
Chemistry · 259d
Cleared May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 151d
Cleared May 19, 2017
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
K163073 · JKA
Sol-Millennium Medical, Inc.
Chemistry · 198d
Not Cleared May 18, 2017
Vitamin D 200M Assay for the Topaz System
DEN170019 · PSL
Ab Sciex, LLC
Chemistry · 59d
Cleared May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
K171168 · JIT
Ortho-Clinical Diagnostics
Chemistry · 25d
Cleared May 12, 2017
iChemVELOCITY Automated Urine Chemistry System
K171083 · JIL
Iris Diagnostics, A Division of Iris...
Chemistry · 31d
Cleared May 12, 2017
N Latex Cystatin C
K171072 · NDY
Siemens Healthcare Diagnostics...
Chemistry · 32d
Cleared May 10, 2017
ALP IFCC Gen.2
K171080 · CJE
Roche Diagnostics Operations (Rdo)
Chemistry · 29d
Cleared May 02, 2017
iGlucose Blood Glucose Monitoring System
K161790 · NBW
Bionime Corporation
Chemistry · 307d
Cleared Apr 28, 2017
ABL90 FLEX, ABL90 FLEX PLUS
K170882 · MQM
Radiometer Medical Aps
Chemistry · 35d
Cleared Apr 28, 2017
Randox RX Daytona Plus Magnesium (MG)
K162200 · JGJ
Randox Laboratories, Ltd.
Chemistry · 266d
Cleared Apr 26, 2017
CalSet IGF-1
K170938 · JIT
Roche Diagnostics
Chemistry · 27d
Cleared Apr 21, 2017
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
K162275 · CJE
Randox Laboratories Limited
Chemistry · 252d
Cleared Apr 21, 2017
VivaChek Ino Blood Glucose Monitoring System
K160179 · NBW
Vivachek Laboratories, Inc.
Chemistry · 450d
Cleared Apr 14, 2017
Smart Dongle Blood Glucose Monitoring System
K162382 · NBW
Taidoc Technology Corporation
Chemistry · 233d
Cleared Apr 11, 2017
Nova Max Uric Acid Monitoring System
K160990 · PTC
Nova Biomedical Corporation
Chemistry · 368d
Cleared Apr 10, 2017
i-Stat Alinity System with i-Stat Glucose test
K163271 · CGA
Abbott Point of Care, Inc.
Chemistry · 140d