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
2185–2208 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 22, 2007
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND...
K063351 · NDY
Dade Behring, Inc.
Chemistry · 77d
Cleared Jan 22, 2007
EUKARE
K062892 · CGA
Eumed Biotechnology Co., Ltd.
Chemistry · 118d
Cleared Jan 19, 2007
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K063208 · JGJ
Diagnostic Chemicals , Ltd.
Chemistry · 88d
Cleared Jan 19, 2007
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
K062503 · KWW
Catachem, Inc.
Chemistry · 147d
Cleared Jan 17, 2007
COBAS INTEGRA C 111
K063744 · CIG
Rochdiag
Chemistry · 30d
Cleared Jan 12, 2007
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
K063409 · NBW
Agamatrix
Chemistry · 60d
Cleared Jan 12, 2007
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
K062966 · ORH
Seradyn, Inc.
Chemistry · 105d
Cleared Jan 12, 2007
CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/...
K062800 · NBW
Taidoc Technology Corporation
Chemistry · 115d
Cleared Jan 12, 2007
EASYGLUCO, MODEL IGM-0002 G2
K061431 · CGA
U. S. Diagnostics, Inc.
Chemistry · 233d
Cleared Jan 05, 2007
VITROS CHEMISTRY PRODUCTS BARB REAGENT
K062165 · DIS
Ortho-Clinical Diagnostics
Chemistry · 161d
Cleared Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276 · JIL
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · LPS
Dade Behring, Inc.
Chemistry · 66d
Cleared Dec 27, 2006
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT...
K063643 · LCP
Bio-Rad Laboratories Inc., Clinical...
Chemistry · 20d
Cleared Dec 27, 2006
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
K062555 · NBW
Visgeneer, Inc.
Chemistry · 119d
Cleared Dec 26, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
K062924 · NQD
Dade Behring, Inc.
Chemistry · 89d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS...
K063543 · CIG
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Dec 22, 2006
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
K063224 · NZB
Gentris Corporation
Chemistry · 59d
Cleared Dec 22, 2006
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
K063057 · NQD
Diagnostic Products Corporation
Chemistry · 78d
Cleared Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062285 · JXM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 137d
Cleared Dec 20, 2006
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
K063068 · NBW
Arkray USA, Inc.
Chemistry · 75d
Cleared Dec 20, 2006
CORTISOL ELISA
K062626 · CGR
Ibl-Hamburg GmbH
Chemistry · 106d
Cleared Dec 19, 2006
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE...
K062838 · MMI
Ortho-Clinical Diagnostics
Chemistry · 89d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY...
K063591 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE...
K062460 · DJG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d