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
913–936 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Nov 19, 2014
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
K133303 · JKA
Bio-Analysis, Inc.
Chemistry · 390d