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
985–1008 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Apr 10, 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
K140648 · JIT
Tosoh Bioscience, Inc.
Chemistry · 28d