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
601–624 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 13, 2017
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose...
K170241 · NBW
All Medicus Co., Ltd.
Chemistry · 260d
Cleared Oct 13, 2017
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
K170232 · JLW
Boditech Med, Inc.
Chemistry · 261d
Cleared Oct 12, 2017
Lucica Glycated Albumin-L
K170147 · LCP
Asahi Kasei Pharma Corporation
Chemistry · 268d
Cleared Oct 06, 2017
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood...
K170079 · NBW
Tyson Bioresearch, Inc.
Chemistry · 269d
Cleared Oct 05, 2017
Gold AQ Blood Glucose Monitoring System
K170264 · NBW
Changsha Sinocare, Inc.
Chemistry · 251d
Cleared Sep 27, 2017
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 91d
Cleared Sep 21, 2017
Scanostics UTI Check Application Test System
K170118 · JMT
Teco Diagnostics
Chemistry · 251d
Cleared Sep 21, 2017
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
K163462 · JHX
Radiometer Medical Aps
Chemistry · 286d
Cleared Sep 20, 2017
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
K171822 · NBW
Biotest Medical Corporation
Chemistry · 93d
Cleared Sep 18, 2017
VITROS Chemistry Products GLU Slides
K163433 · CGA
Ortho-Clinical Diagnostics
Chemistry · 285d
Cleared Sep 15, 2017
WowGoHealth Blood Glucose Monitoring System
K171785 · NBW
Biotest Medical Corporation
Chemistry · 92d
Cleared Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · NBW
Andon Health Co, Ltd.
Chemistry · 233d
Cleared Sep 12, 2017
CAPI 3 Hb A1c
K171537 · PDJ
Sebia
Chemistry · 110d
Cleared Aug 18, 2017
Diazyme DZ-Lite Total beta-hCG Test System
K163418 · DHA
Diazyme Laboratories
Chemistry · 255d
Cleared Aug 18, 2017
s LDL-EX SEIKEN
K161679 · PYP
Denka Seiken Co., Ltd.
Chemistry · 427d
Cleared Aug 16, 2017
GLUCOCARD W Blood Glucose Monitoring System
K170064 · NBW
Arkray Factory, Inc.
Chemistry · 219d
Cleared Jul 28, 2017
Lumipulse G TSH-III Immunoreaction Cartridges
K171103 · JLW
Fujirebio Diagnostics,Inc.
Chemistry · 106d
Cleared Jul 28, 2017
cobas HbA1c Test, cobas b 101 system
K163633 · LCP
Roche Diagnostics Operations
Chemistry · 218d
Cleared Jul 21, 2017
Teco Creatinine Enzymatic Reagent Kit
K161527 · JFY
Teco Diagnostics, Inc.
Chemistry · 414d
Cleared Jul 19, 2017
Dario Blood Glucose Monitoring System
K163159 · NBW
Labstyle Innovations, Ltd.
Chemistry · 251d
Cleared Jul 14, 2017
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
K162698 · JLW
Shenzhen New Industries Biomedical...
Chemistry · 290d
Cleared Jul 14, 2017
VITROS Chemistry Products hsCRP Reagent
K160712 · DCK
Ortho-Clinical Diagnostics
Chemistry · 486d
Cleared Jul 11, 2017
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems...
K171401 · CIG
Elitechgroup
Chemistry · 60d
Cleared Jul 11, 2017
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · CHH
ACON Laboratories, Inc.
Chemistry · 218d