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
457–480 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 26, 2019
ACR LAB Urine Analysis Test System
K182384 · JFY
Healthy.Io, Ltd.
Chemistry · 329d
Cleared Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191365 · JGS
Nova Biomedical Corporation
Chemistry · 58d
Cleared Jul 18, 2019
DreaMed Advisor Pro
K191370 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 57d
Cleared Jun 28, 2019
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K191450 · QBJ
Dexcom, Inc.
Chemistry · 28d
Cleared Jun 17, 2019
IDS SHBG
K190121 · CDZ
Immunodiagnostic Systems , Ltd.
Chemistry · 143d
Cleared Jun 12, 2019
On Call Express Voice Blood Glucose Monitoring System
K191038 · NBW
ACON Laboratories, Inc.
Chemistry · 55d
Cleared Jun 12, 2019
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent,...
K172232 · JGS
Ams Diagnostics
Chemistry · 687d
Cleared Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
K191316 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared Jun 04, 2019
TD-4183 Blood Glucose Monitoring System
K190579 · NBW
Taidoc Technology Corporation
Chemistry · 90d
Cleared Jun 02, 2019
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose...
K190564 · NBW
Bionime Corporation
Chemistry · 89d
Cleared May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 63d
Cleared May 15, 2019
VeriClear Digital Early Result Pregnancy Test
K182328 · LCX
True Diagnostics, Inc.
Chemistry · 261d
Cleared May 08, 2019
GlucoLeader Enhance Blood Glucose Monitoring System
K182428 · NBW
Hmd Biomedical, Inc.
Chemistry · 244d
Cleared May 07, 2019
cobas u 601 urinalysis test system
K183432 · JIL
Roche Diagnostics
Chemistry · 147d
Cleared May 03, 2019
NeoLSD MSMS Kit
K190266 · PQW
Perkinelmer, Inc.
Chemistry · 84d
Cleared May 02, 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN...
K182474 · JFJ
Biosystems S.A.
Chemistry · 234d
Cleared Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · CIG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 17, 2019
SEKURE Creatine Kinase Assay
K182702 · CGS
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 202d
Cleared Apr 16, 2019
Elecsys TSH
K190773 · JLW
Roche Diagnostics
Chemistry · 21d
Cleared Apr 15, 2019
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test...
K190705 · LCX
Wholepower Biotech Co., Ltd.
Chemistry · 27d
Cleared Apr 12, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K181915 · LCP
Ixensor Co, Ltd.
Chemistry · 269d
Cleared Apr 10, 2019
GLUCOCARD® W onyx Blood Glucose Monitoring System
K183306 · NBW
Arkray Factory, Inc.
Chemistry · 133d
Cleared Apr 03, 2019
VITROS XT Chemistry Products GLU-Ca Slides
K190520 · CGA
Ortho-Clinical Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · CHH
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d