FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
1345–1368 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 06, 2012
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM,...
K120448 · CGA
Apex BioTechnology Corp.
Chemistry · 52d
Cleared Mar 30, 2012
DIAZYME CYSTATIN C POC TEST KIT
K111664 · NDY
Diazyme Laboratories
Chemistry · 290d
Cleared Mar 29, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 31d
Cleared Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K112538 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 210d
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 Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894 · LFR
Bayer Healthcare
Chemistry · 364d
Cleared 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 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