FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
793–816 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 20, 2015
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH...
K151792 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 142d
Cleared Nov 19, 2015
Gmate SMART Blood Glucose Monitoring System
K150299 · NBW
Philosys, Inc.
Chemistry · 286d
Cleared Oct 26, 2015
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set,...
K150270 · MRG
Tosoh Bioscience, Inc.
Chemistry · 264d
Cleared Oct 14, 2015
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro...
K150396 · NBW
Apex BioTechnology Corp.
Chemistry · 238d
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