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
961–984 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 02, 2014
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
K140690 · CDQ
Shenzhen Mindray Bio-Medical...
Chemistry · 167d
Cleared Aug 29, 2014
ACCU-CHEK Performa Blood Glucose Monitoring System
K133741 · NBW
Roche Diagnostics
Chemistry · 263d
Cleared Aug 25, 2014
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · LCM
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 28d
Cleared Aug 22, 2014
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS...
K140210 · NBW
Bionime Corporation
Chemistry · 206d
Not Cleared Aug 19, 2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
DEN140016 · PHV
Dexcom, Inc.
Chemistry · 119d
Cleared Aug 14, 2014
OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
K132633 · NBW
Ok Biotech Co., Ltd.
Chemistry · 357d
Cleared Aug 12, 2014
Elecsys Estradiol III CalSet
K142021 · JIT
Roche Diagnostics
Chemistry · 18d
Cleared Aug 08, 2014
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K133751 · JIT
Diamond Diagnostics, Inc.
Chemistry · 242d
Cleared Aug 06, 2014
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
K133803 · LCP
Diazyme Laboratories
Chemistry · 233d
Cleared Aug 04, 2014
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
K131230 · NBW
Philosys, Inc.
Chemistry · 461d
Cleared Aug 01, 2014
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO...
K140100 · NBW
Nipro Diagnostics, Inc.
Chemistry · 198d
Cleared Jul 28, 2014
ACE CALIBRATOR
K141728 · JIT
SENTINEL CH. SpA
Chemistry · 32d
Cleared Jul 24, 2014
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
K141750 · LCP
Infopia Co, Ltd.
Chemistry · 24d
Cleared Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 280d
Cleared Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265 · JHW
Elitechgroup
Chemistry · 64d
Cleared Jul 17, 2014
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP,...
K141647 · DIO
Healgen Scientific, LLC
Chemistry · 28d
Cleared Jul 17, 2014
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR,...
K141143 · NDY
Roche Diagnostics
Chemistry · 76d
Cleared Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829 · LCP
Beckman Coulter, Inc.
Chemistry · 104d
Cleared Jul 11, 2014
SYSTEM CALIBRATER
K141388 · JIX
Beckman Coulter Ireland, Inc.
Chemistry · 45d
Cleared Jul 11, 2014
ABX PENTRA MICRO ALB CONTROL L/H
K133676 · JJY
HORIBA ABX SAS
Chemistry · 224d
Cleared Jul 09, 2014
IMMULITE 2000
K141444 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Jul 03, 2014
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K140141 · NBW
Ceragem Medisys, Inc.
Chemistry · 162d
Cleared Jun 30, 2014
BICARBONATE CALIBRATOR
K141374 · JIT
Beckman Coulter Ireland, Inc.
Chemistry · 34d
Cleared Jun 30, 2014
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD...
K124021 · CGA
Arkray Factory, Inc.
Chemistry · 550d