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
745–768 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 17, 2016
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone...
K161082 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared Apr 27, 2016
Elecsys Cortisol II, Cortisol II CalSet
K152227 · JFT
Roche Diagnostics
Chemistry · 264d
Cleared Apr 25, 2016
POGO Automatic Blood Glucose Monitoring System
K152493 · NBW
Intuity Medical, Inc.
Chemistry · 237d
Cleared Apr 22, 2016
CueSee Hypoxic
K152553 · JJS
Eurotrol B.V.
Chemistry · 227d
Cleared Apr 21, 2016
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
K152365 · NBW
Agamatrix, Inc.
Chemistry · 244d
Cleared Apr 21, 2016
Dropper hsCRP High Sensitivity CRP Control
K152117 · JJX
Quantimetrix Corporation
Chemistry · 266d
Cleared Apr 15, 2016
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K153361 · MRG
Fujirebio Diagnostics,Inc.
Chemistry · 147d
Cleared Apr 08, 2016
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · KXT
Roche Diagnostics
Chemistry · 147d
Cleared Apr 07, 2016
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
K142754 · LCX
Sugentech, Inc.
Chemistry · 560d
Cleared Apr 01, 2016
TRUE METRIX GO Self Monitoring Blood Glucose System
K143548 · NBW
Trividia Health, Inc.
Chemistry · 473d
Cleared Mar 07, 2016
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K152835 · JFY
Teco Diagnostics, Inc.
Chemistry · 160d
Cleared Feb 24, 2016
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG...
K152768 · JHI
Assure Tech. Co., Ltd.
Chemistry · 153d
Cleared Feb 24, 2016
Liquid CO2-2 (LCO2-2)
K152085 · KHS
Randox Laboratories, Ltd.
Chemistry · 212d
Cleared Feb 19, 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 92d
Cleared Feb 17, 2016
ST AIA-PACK hsE2 Calibrator Set
K160113 · JIT
Tosoh Bioscience, Inc.
Chemistry · 29d
Cleared Feb 17, 2016
FREND™ Free T4 Test System
K152422 · CEC
Nanoentek USA, Inc.
Chemistry · 175d
Cleared Feb 16, 2016
Direct Bilirubin
K152343 · JFM
Randox Laboratories Limited
Chemistry · 181d
Cleared Feb 12, 2016
BD Vacutainer UltraTouch Push Button Blood Collection Set
K153309 · JKA
Becton, Dickinson and Company
Chemistry · 87d
Cleared Feb 11, 2016
ARCHITECT SHBG
K152185 · CDZ
Biokit, S.A.
Chemistry · 190d
Cleared Feb 11, 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension...
K151529 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 248d
Cleared Jan 29, 2016
URight Hemoglobin A1c system, FORA A1c System
K142664 · LCP
Taidoc Technology Corporation
Chemistry · 498d
Cleared Jan 28, 2016
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7...
K153712 · JJY
Radiometer America, Inc.
Chemistry · 35d
Cleared Jan 28, 2016
Total Bilirubin
K152344 · JFM
Randox Laboratories Limited
Chemistry · 162d
Cleared Jan 27, 2016
StatStrip Xpress 2 Glucose Hospital Meter System
K152986 · PZI
Nova Biomedical Corporation
Chemistry · 110d