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
961–984 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 30, 2014
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD...
K124021 · CGA
Arkray Factory, Inc.
Chemistry · 550d
Cleared Jun 27, 2014
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE...
K133260 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 247d
Cleared Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 86d
Cleared Jun 25, 2014
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
K132180 · NBW
Ideal Life, Inc.
Chemistry · 345d
Cleared Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
K130265 · NBW
Bayer Healthcare, LLC
Chemistry · 504d
Cleared Jun 06, 2014
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
K140546 · LDJ
Healgen Scientific, LLC
Chemistry · 94d
Cleared May 29, 2014
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · JIL
Teco Diagnostics
Chemistry · 360d
Cleared May 22, 2014
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND...
K140522 · JJY
Randox Laboratories Limited
Chemistry · 79d
Cleared May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
K140373 · JGS
Roche Diagnostics
Chemistry · 97d
Cleared May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
K133790 · NBW
Andon Health Co, Ltd.
Chemistry · 164d
Cleared May 16, 2014
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER
K133519 · JJE
Carolina Liquid Chemistries Corp.
Chemistry · 182d
Cleared May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
K130915 · JJE
Jas Diagnostics, Inc.
Chemistry · 408d
Cleared May 13, 2014
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC...
K130080 · JHY
Medica Corporation
Chemistry · 484d
Cleared May 08, 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · JHY
Roche Diagnostics
Chemistry · 79d
Cleared May 08, 2014
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
K132711 · LBS
Carolina Liquid Chemistries Corp.
Chemistry · 252d
Cleared May 06, 2014
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
K140916 · JJY
Bio-Rad Laboratories
Chemistry · 26d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I...
K140818 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 29, 2014
ACCU-CHEK AVIVA PLUS SYSTEM
K133862 · NBW
Roche Diagnostics Corporation
Chemistry · 131d
Cleared Apr 28, 2014
GSP NEONATAL TOTAL GALACTOSE KIT
K133652 · JIA
Wallac Oy, A Subsidiary of...
Chemistry · 152d
Cleared Apr 28, 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD...
K133537 · LFR
Eps Bio Technology Corp.
Chemistry · 161d
Cleared Apr 18, 2014
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
K132406 · NBW
Infopia Co, Ltd.
Chemistry · 259d
Cleared Apr 17, 2014
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED...
K133522 · NBW
Bionime Coporation
Chemistry · 153d
Cleared Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · CFR
Beckman Coulter, Inc.
Chemistry · 356d
Cleared Apr 15, 2014
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
K133389 · NBW
Eps Bio Technology Corp.
Chemistry · 161d