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
625–648 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent...
K170587 · JIN
ACON Laboratories, Inc.
Chemistry · 128d
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