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
817–840 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 13, 2015
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose...
K140325 · NBW
Joinsoon Medical Technology Co, Ltd.
Chemistry · 610d
Cleared Oct 09, 2015
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
K150502 · DJG
Microgenics Corporation
Chemistry · 225d
Cleared Oct 06, 2015
ARIES System
K151917 · OOI
Luminex Corporation
Chemistry · 85d
Cleared Oct 05, 2015
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split...
K152025 · DJR
Assure Tech. Co., Ltd.
Chemistry · 75d
Cleared Oct 02, 2015
Elecsys Progesterone III CalSet
K152526 · JIT
Roche Diagnostics
Chemistry · 29d
Cleared Oct 02, 2015
One Step hCG Pregnancy Test
K150063 · LCX
Coretests, Inc.
Chemistry · 262d
Cleared Oct 02, 2015
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE...
K141656 · NBW
Philosys, Inc.
Chemistry · 469d
Cleared Sep 30, 2015
FreeStyle Precision Neo Blood Glucose Monitoring System
K142928 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 356d
Cleared Sep 30, 2015
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
K140827 · LCP
Sd Biosensor, Inc.
Chemistry · 547d
Cleared Sep 29, 2015
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood...
K151100 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Sep 29, 2015
Cholesterol
K150654 · CHH
Randox Laboratories, Ltd.
Chemistry · 200d
Cleared Sep 25, 2015
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
K151809 · LCP
Alere Technologies AS
Chemistry · 85d
Cleared Sep 24, 2015
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786 · CDD
Roche Diagnostics
Chemistry · 85d
Cleared Sep 23, 2015
Contour Next Control Solution
K151742 · JJX
Bayer Healthcare
Chemistry · 86d
Cleared Sep 18, 2015
Dimension Vista MMB Assay
K143720 · JHY
Siemens Healthcare Diagnostics
Chemistry · 263d
Cleared Sep 17, 2015
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · LFR
Abott Laboratories
Chemistry · 30d
Cleared Sep 10, 2015
Stat Profile Prime ABG Analyzer System
K151982 · CHL
Nova Biomedical Corporation
Chemistry · 55d
Cleared Sep 05, 2015
On Call Express Pro Blood Glucose Monitoring System
K151595 · NBW
ACON Laboratories, Inc.
Chemistry · 85d
Cleared Aug 26, 2015
GDH Professional Blood Glucose Monitoring System and GDH Professional LED...
K150274 · NBW
Infopia Co, Ltd.
Chemistry · 203d
Cleared Aug 25, 2015
25-Hydroxy Vitamin Ds EIA
K142351 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 368d
Cleared Aug 13, 2015
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K151642 · JXM
Healgen Scientific, LLC
Chemistry · 56d
Cleared Aug 07, 2015
Assure Prism multi Blood Glucose Monitoring System
K151164 · NBW
I-Sens, Inc.
Chemistry · 98d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
K150022 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 213d
Cleared Aug 06, 2015
ABL80 FLEX CO-OX with AQURE connectivity
K151856 · CHL
Sendx Medical, Inc.
Chemistry · 29d