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
1153–1176 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 17, 2013
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
K130535 · NBW
Agamatrix, Inc.
Chemistry · 47d
Cleared Apr 17, 2013
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK...
K124009 · JJY
Diamond Diagnostics, Inc.
Chemistry · 111d
Cleared Apr 12, 2013
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
K123935 · NBW
Andon Medical Co., Ltd.
Chemistry · 113d
Cleared Apr 10, 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY...
K123703 · LCX
Healgen Scientific, LLC
Chemistry · 128d
Cleared Apr 09, 2013
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE...
K130321 · CJM
Diasorin
Chemistry · 60d
Cleared Apr 05, 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · JIT
Siemens Healthcare Diagnostics
Chemistry · 22d
Cleared Apr 05, 2013
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON...
K130469 · JLW
DiaSorin, Inc.
Chemistry · 39d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · NBW
Abbott Laboratories
Chemistry · 186d
Cleared Apr 05, 2013
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
K122307 · NBW
Biocare Corporation
Chemistry · 247d
Cleared Apr 04, 2013
ELITECH CLINICAL SYSTEMS ELICAL 2
K130765 · JIX
Elitechgroup
Chemistry · 15d
Cleared Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · LFR
Nova Biomedical Corporation
Chemistry · 212d
Cleared Apr 04, 2013
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON...
K121951 · CEC
DiaSorin, Inc.
Chemistry · 275d
Cleared Mar 27, 2013
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER,...
K121823 · JFS
Wescor, Inc.
Chemistry · 279d
Cleared Mar 26, 2013
HIGH METABOLITE QUALICHECK
K130415 · JJS
Radiometer Medical Aps
Chemistry · 35d
Cleared Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
K130276 · JJE
Siemens Healthcare Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 22, 2013
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
K130141 · CJE
Hitachi Chemical Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 22, 2013
AXIS-SHIELD ACVTIVE-B12
K121946 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Mar 22, 2013
ALCO-SCREEN
K121247 · DIC
Chematics, Inc.
Chemistry · 331d
Cleared Mar 21, 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · CEW
Siemens Healthcare Diagnostics
Chemistry · 258d
Cleared Mar 19, 2013
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
K130157 · JJX
Aalto Scientific, Ltd.
Chemistry · 55d
Cleared Mar 15, 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK...
K130236 · JJS
Radiometer Medical Aps
Chemistry · 44d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · NBW
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 14, 2013
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · LCX
Polymed Therapeutics, Inc.
Chemistry · 174d
Cleared Mar 12, 2013
PERKINELMER 226 SAMPLE COLLECTION DEVICES
K121864 · PJC
Perkinelmer, Inc.
Chemistry · 259d