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
1753–1776 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 24, 2009
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
K092104 · CGA
Arkray Factory USA, Inc.
Chemistry · 133d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 20, 2009
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814 · CGA
Taidoc Technology Corporation
Chemistry · 155d
Cleared Nov 19, 2009
MICRODOT XTRA
K083273 · NBW
Cambridge Sensors Limited
Chemistry · 378d
Cleared Nov 17, 2009
EASYRA MG REAGENT, MODEL 10220
K092737 · JGJ
Medica Corp.
Chemistry · 70d
Cleared Nov 17, 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
K091157 · NBW
Infopia Co, Ltd.
Chemistry · 210d
Cleared Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
K092168 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Nov 16, 2009
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
K091815 · NBW
Biotest Medical Corp.
Chemistry · 151d
Cleared Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032 · JJY
Biosite Incorporated
Chemistry · 45d
Cleared Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
K092320 · JJY
Roche Diagnostics
Chemistry · 91d
Cleared Oct 26, 2009
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL...
K091413 · CHH
Alfa Wassermann, Inc.
Chemistry · 166d
Cleared Oct 23, 2009
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
K091102 · CGA
Arkray Factory USA, Inc.
Chemistry · 190d
Cleared Oct 21, 2009
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
K092887 · NBW
Eps Bio Technology Corp.
Chemistry · 30d
Cleared Oct 20, 2009
POLY-CHEM 90 GLUCOSE
K090703 · CFR
Polymedco, Inc.
Chemistry · 217d
Cleared Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
K092570 · JIT
HORIBA ABX SAS
Chemistry · 56d
Cleared Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · JFJ
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260 · DDR
Roche Diagnostics
Chemistry · 345d
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · JIL
Siemens Healthcare Diagnostics
Chemistry · 165d
Cleared Oct 09, 2009
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
K090653 · NBW
Arkray Factory USA, Inc.
Chemistry · 212d
Cleared Oct 02, 2009
AIA-PACK RBC FOLATE
K091332 · CGN
Tosoh Bioscience, Inc.
Chemistry · 149d
Cleared Oct 02, 2009
EOCENE SYSTEM
K090712 · NBW
Infopia Co, Ltd.
Chemistry · 198d
Cleared Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · JGJ
Abaxis, Inc.
Chemistry · 98d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · JJX
Roche Diagnostics Corp.
Chemistry · 114d