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
1609–1632 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
K103221 · JIT
Roche Diagnostics
Chemistry · 52d
Cleared Dec 23, 2010
AUDIT MICROCV HS-CRP LINEARITY SET
K101427 · JJX
Aalto Scientific, Ltd.
Chemistry · 216d
Cleared Dec 23, 2010
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
K100715 · JJX
Aalto Scientific, Ltd.
Chemistry · 286d
Cleared Dec 21, 2010
LIPID CONTROLS
K102700 · JJY
Alere, San Diego, Dba Biosite...
Chemistry · 92d
Cleared Dec 21, 2010
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
K100937 · NBW
I-Sens, Inc.
Chemistry · 260d
Cleared Dec 17, 2010
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
K103360 · JIT
Siemens Corp.
Chemistry · 31d
Cleared Dec 16, 2010
GSP NEONATAL IRT KIT (3306-001U)
K102419 · JNO
Wallac Oy, Subsidiary of Perkinelmer
Chemistry · 113d
Cleared Dec 15, 2010
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2,...
K100525 · CGA
Seppim S.A.S.
Chemistry · 294d
Cleared Dec 15, 2010
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL...
K100060 · KHS
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 338d
Cleared Dec 10, 2010
ABL837 FLEX ANALYZER
K100777 · CHL
Radiometer Medical Aps
Chemistry · 267d
Cleared Dec 06, 2010
PRECICONTROL HBA1C NORM
K103099 · JJX
Roche Diagnostics
Chemistry · 47d
Cleared Nov 30, 2010
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
K102638 · JIT
Diazyme Laboratories
Chemistry · 77d
Cleared Nov 23, 2010
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
K102904 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 18, 2010
ELECSYS PTH CALCHECK 5
K103162 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared Nov 17, 2010
BGM GALECTIN -3
K093758 · OSX
Bg Medicine, Inc.
Chemistry · 345d
Cleared Nov 09, 2010
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
K103041 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 26d
Cleared Oct 22, 2010
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS...
K101921 · CEW
Ortho-Clinical Diagnostics
Chemistry · 105d
Cleared Oct 20, 2010
NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
K102441 · MMI
Nano-Ditech Corporation
Chemistry · 83d
Cleared Oct 20, 2010
NANO-CHECK AMI CTNI CARDIAC MARKER TEST
K102131 · MMI
Nano-Ditech Corporation
Chemistry · 83d
Cleared Oct 18, 2010
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
K101597 · NBW
Agamatrix
Chemistry · 132d
Cleared Oct 18, 2010
MEDTOX BUPRENORPHINE TEST
K100951 · DJG
Medtox Diagnostics, Inc.
Chemistry · 195d
Cleared Sep 28, 2010
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL,...
K100550 · LBS
Polymedco, Inc.
Chemistry · 214d
Cleared Sep 28, 2010
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · NDY
Kamiya Biomedical Co.
Chemistry · 358d
Cleared Sep 24, 2010
FDI GLUCOSE CONTROL SOLUTIONS
K102260 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 45d