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
937–960 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Not Cleared Sep 05, 2014
NEPHROCHECK TEST SYSTEM
DEN130031 · PIG
Astute Medical, Inc.
Chemistry · 457d
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