FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
1417–1440 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 22, 2011
PREMIER HB9210 HBA1C ANALYZER
K112015 · LCP
Primus Corporation Dba Trinity Biotech
Chemistry · 132d
Cleared Nov 21, 2011
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · DJZ
Seju Engineering Co., Ltd.
Chemistry · 263d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS...
K111960 · KHS
Elitechgroup
Chemistry · 130d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL...
K103376 · JFY
Seppim S.A.S.
Chemistry · 366d
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