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
1177–1200 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113 · KHP
Abaxis, Inc.
Chemistry · 54d