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
625–648 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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 CT 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
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent...
K170587 · JIN
ACON Laboratories, Inc.
Chemistry · 128d