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
1441–1464 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 10, 2011
IGLUCOSE SYSTEM
K111932 · NBW
Positiveid Corporation
Chemistry · 125d
Cleared Nov 09, 2011
CPK REAGENT
K112416 · CGS
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 79d
Cleared Nov 09, 2011
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
K111509 · NBW
Sweetspot Diabetes Care, Inc.
Chemistry · 161d
Cleared Nov 08, 2011
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
K103788 · CFR
HORIBA ABX SAS
Chemistry · 316d
Cleared Nov 04, 2011
POLY-CHEM 90 ISE MODULE
K112408 · CEM
Polymedco, Inc.
Chemistry · 74d
Cleared Nov 04, 2011
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
K112142 · NDW
Siemens Healthcare Diagnostics
Chemistry · 101d
Cleared Nov 04, 2011
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103021 · NBW
Infopia Co, Ltd.
Chemistry · 388d
Cleared Nov 03, 2011
THERMO SCIENTIFIC MAS OMNI-CORE
K110738 · JJY
Microgenics Corporation
Chemistry · 231d
Cleared Oct 28, 2011
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103278 · CGA
I-Sens, Inc.
Chemistry · 357d
Cleared Oct 20, 2011
EASTLYTE NA/K/CA/PH
K112788 · CEM
Medica Corp.
Chemistry · 24d
Cleared Oct 18, 2011
ELECSYS T4 CALCHECK 5
K112528 · JJX
Roche Diagnostics Corporation
Chemistry · 48d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 227d
Cleared Oct 14, 2011
RANDOX DIGOXIN ASSAY
K102346 · KXT
Randox Laboratories, Ltd.
Chemistry · 421d
Cleared Oct 12, 2011
PRODIGY DIABETES MANAGEMENT SOFTWARE
K103115 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 356d
Cleared Oct 11, 2011
HEALTH-E-CONNECT SYSTEM
K102063 · NBW
Alr Technologies
Chemistry · 445d
Cleared Oct 07, 2011
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL...
K110780 · CIG
Elitechgroup
Chemistry · 200d
Cleared Oct 07, 2011
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION...
K102772 · OAV
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 378d
Cleared Oct 07, 2011
GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
K102316 · CGA
Broadmaster Biotech Corporation
Chemistry · 417d
Cleared Oct 06, 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · CGA
ACON Laboratories, Inc.
Chemistry · 143d
Cleared Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · CDD
Abbott Laboratories
Chemistry · 219d
Cleared Oct 04, 2011
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K111206 · DIC
Teco Diagnostics
Chemistry · 158d
Cleared Oct 04, 2011
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · LCX
Taidoc Technology Corporation
Chemistry · 312d
Cleared Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · NBW
Andon Medical Co., Ltd.
Chemistry · 10d
Cleared Sep 30, 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · JJY
Randox Laboratories, Ltd.
Chemistry · 183d