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
433–456 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 06, 2019
GSP Neonatal Total Galactose kit
K190335 · JIA
Perkinelmer, Inc.
Chemistry · 265d
Cleared Nov 05, 2019
TAP Blood Collection Device
K190225 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 273d
Cleared Nov 01, 2019
MDT2 BLE Self-Monitoring Blood Glucose System
K190189 · NBW
Eps Bio Technology Corp.
Chemistry · 273d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · LCP
Ixensor Co, Ltd.
Chemistry · 60d
Cleared Oct 25, 2019
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
K192787 · QDK
Dexcom, Inc.
Chemistry · 25d
Cleared Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
K192175 · NBW
ACON Laboratories, Inc.
Chemistry · 66d
Cleared Oct 07, 2019
Dexcom G6 Pro Continuous Glucose Monitoring System
K191833 · QII
Dexcom, Inc.
Chemistry · 90d
Cleared Oct 04, 2019
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate,...
K190298 · CDD
Beckman Coulter Biomedical GmbH
Chemistry · 235d
Cleared Oct 03, 2019
Yumizen C1200 CRP
K191993 · DCK
HORIBA ABX SAS
Chemistry · 70d
Cleared Oct 02, 2019
LIAISON Vitamin B12
K192064 · CDD
DiaSorin, Inc.
Chemistry · 62d
Cleared Sep 20, 2019
Omnipod DASH Insulin Management System with interoperable technology
K191679 · QFG
Insulet Corporation
Chemistry · 88d
Cleared Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 88d
Cleared Sep 05, 2019
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip,...
K192123 · LCX
Qingdao Hightop Biotech Co., Ltd.
Chemistry · 30d
Cleared Aug 30, 2019
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · CJE
HORIBA ABX SAS
Chemistry · 113d
Cleared Aug 30, 2019
Lumipulse G whole PTH
K190702 · CEW
Fujirebio Diagnostics,Inc.
Chemistry · 165d
Cleared Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 79d
Cleared Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro...
K191899 · CFR
Roche Diagnostics
Chemistry · 31d
Cleared Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · JFP
Nova Biomedical Corporation
Chemistry · 59d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230 · LCP
Drawbridge Health, Inc.
Chemistry · 268d
Cleared Aug 01, 2019
MAGLUMI 2000 25-OH Vitamin D
K191499 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 56d
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454 · JFJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 29, 2019
Quantisal II Oral Fluid Collection Device
K183048 · PJD
Immunalysis Corporation
Chemistry · 269d
Cleared Jul 26, 2019
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396 · CJY
HORIBA ABX SAS
Chemistry · 63d