FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
889–912 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 07, 2015
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity...
K141689 · DCK
Qualigen, Inc.
Chemistry · 198d
Cleared Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT...
K140436 · OSX
Fujirebio Diagnostics,Inc.
Chemistry · 305d
Cleared Dec 22, 2014
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (...
K142391 · JFY
ACON Laboratories, Inc.
Chemistry · 117d
Cleared Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access...
K142373 · MRG
Beckman Coulter, Inc.
Chemistry · 119d
Cleared Dec 19, 2014
Elecsys T-Uptake Calset
K143342 · JIT
Roche Diagnostics
Chemistry · 28d
Cleared Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access...
K142362 · MRG
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Dec 19, 2014
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
K140554 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 290d
Cleared Dec 18, 2014
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS,...
K133047 · LAF
Biophor Diagnostics, Inc.
Chemistry · 447d
Cleared Dec 17, 2014
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089 · LFR
Roche Diagnostics Corporation
Chemistry · 138d
Cleared Dec 16, 2014
AIA-PACK C-Peptide Control Set
K143296 · JJX
Tosoh Bioscience, Inc.
Chemistry · 29d
Cleared Dec 16, 2014
Elecsys Estradiol III Calcheck
K143284 · JJX
Roche Diagnostics
Chemistry · 29d
Cleared Dec 16, 2014
A1c iGear System
K142789 · LCP
Sakae Corporation
Chemistry · 81d
Cleared Dec 15, 2014
PLAC TEST FOR LP-PLA2 ACTIVITY
K141575 · NOE
Diadexus, Inc.
Chemistry · 186d
Cleared Dec 10, 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · MRG
DiaSorin, Inc.
Chemistry · 190d
Cleared Dec 09, 2014
TOTAL PROTEIN URINE/CSF GEN.3
K141925 · JIQ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Dec 08, 2014
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
K140971 · JJY
Randox Laboratories Limited
Chemistry · 236d
Cleared Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
K143194 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 03, 2014
ST AIA-PACK PROG II Calibrator Set
K143144 · JIT
Tosoh Bioscience, Inc.
Chemistry · 30d
Cleared Dec 02, 2014
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
K141862 · NBW
H2, Inc.
Chemistry · 145d
Cleared Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA...
K140859 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 237d
Cleared Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI...
K140842 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 238d
Cleared Nov 25, 2014
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
K141928 · DKB
Roche Diagnostics Operations (Rdo)
Chemistry · 132d
Cleared Nov 21, 2014
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
K143026 · JJX
Aalto Scientific, Ltd.
Chemistry · 31d
Cleared Nov 20, 2014
Audit MicroControls Linearity LQ Special Diabetes
K142978 · JJY
Aalto Scientific, Ltd.
Chemistry · 36d