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
769–792 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 27, 2016
Elecsys Cortisol II, Cortisol II CalSet
K152227 · JFT
Roche Diagnostics
Chemistry · 264d
Cleared CT 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
Cleared Jan 14, 2016
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose...
K151487 · CFR
Diatron U.S., Inc.
Chemistry · 226d