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
1369–1392 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 29, 2012
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
K110737 · NBW
Bionime Corporation
Chemistry · 379d
Cleared Mar 28, 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS...
K113547 · CGA
Apex BioTechnology Corp.
Chemistry · 118d
Cleared Mar 28, 2012
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243 · LFR
Eps Bio Technology Corp.
Chemistry · 147d
Cleared Mar 28, 2012
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY...
K112834 · JIX
Verichem Laboratories, Inc.
Chemistry · 182d
Cleared CT Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894 · LFR
Bayer Healthcare
Chemistry · 364d
Cleared CT Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
K110587 · LFR
Bayer Healthcare, LLC
Chemistry · 393d
Cleared Mar 27, 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE...
K120504 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Mar 23, 2012
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
K112377 · CFR
Shenzhen Mindray Bio-Medical...
Chemistry · 219d
Cleared Mar 23, 2012
BIOLIS 12I
K110520 · CEM
Tokyo Boeki Medisys, Inc.
Chemistry · 394d
Cleared Mar 19, 2012
ABL90 FLEX
K120197 · CHL
Radiometer Medical Aps
Chemistry · 56d
Cleared Mar 13, 2012
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103329 · NBW
Delbio Incorporation
Chemistry · 487d
Cleared Mar 13, 2012
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
K103116 · CGA
Bestgen Biotech Corp.
Chemistry · 509d
Cleared Mar 12, 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 95d
Cleared Mar 09, 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
K112638 · NBW
Nova Biomedical Corporation
Chemistry · 182d
Cleared Mar 09, 2012
MICT TSH
K110761 · JLW
Magnabiosciences, LLC
Chemistry · 357d
Cleared Mar 08, 2012
LIASYS 450
K113131 · CFR
Ams
Chemistry · 136d
Cleared Mar 06, 2012
FORESIGHT U120 URINE ANALYZER
K120124 · JIL
ACON Laboratories, Inc.
Chemistry · 49d
Cleared CT Mar 06, 2012
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
K111268 · LFR
Bayer Healthcare
Chemistry · 307d
Cleared Mar 02, 2012
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
K111964 · JJY
Aalto Scientific, Ltd.
Chemistry · 235d
Cleared Feb 28, 2012
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
K111456 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 279d
Cleared Feb 27, 2012
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
K113007 · JQP
Bionime Corporation
Chemistry · 143d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · LFR
Abbott Laboratories
Chemistry · 230d
Cleared Feb 14, 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION...
K111938 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 221d
Cleared Feb 10, 2012
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL...
K103044 · NBW
Bestgen Biotech Corp.
Chemistry · 484d