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
1585–1608 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 07, 2011
ON CALL PLUS DIABETES MONITORING SOFTWARE
K101371 · NBW
ACON Laboratories, Inc.
Chemistry · 235d
Cleared Jan 07, 2011
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
K093280 · CHL
Opti Medical Systems, Inc.
Chemistry · 444d
Cleared Jan 03, 2011
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113,...
K101853 · NOE
Diadexus, Inc.
Chemistry · 186d
Cleared Dec 28, 2010
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
K102210 · DKZ
Lin-Zhi International, Inc.
Chemistry · 145d
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