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
2689–2712 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 24, 2004
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085
K042442 · DCK
Orion Diagnostica, OY
Chemistry · 15d
Cleared Sep 24, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
K041349 · CHP
Ibl GmbH
Chemistry · 127d
Cleared Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281 · JLW
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS...
K042195 · LBS
Beckman Coulter, Inc.
Chemistry · 34d
Cleared Sep 16, 2004
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822 · DKZ
ACON Laboratories, Inc.
Chemistry · 72d
Cleared Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL...
K042389 · JJY
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Sep 10, 2004
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · LCX
Unipath , Ltd.
Chemistry · 18d
Cleared Sep 10, 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · MMI
Abbott Laboratories
Chemistry · 66d
Cleared Sep 10, 2004
QUICKSCREEN, MODELS 9177X AND 9178X
K041578 · LCM
Phamatech
Chemistry · 88d
Cleared Sep 09, 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · LCX
ACON Laboratories, Inc.
Chemistry · 31d
Cleared Sep 09, 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
K041764 · LCP
Ortho-Clinical Diagnostics
Chemistry · 71d
Cleared Sep 09, 2004
RANDOX TRI LEVEL CARDIAC CONTROL
K041361 · JJY
Randox Laboratories Limited
Chemistry · 111d
Cleared Sep 03, 2004
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
K041627 · NDY
Dako A/S
Chemistry · 79d
Cleared Aug 30, 2004
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
K041657 · KQN
Thermo Electron Corporation
Chemistry · 73d
Cleared Aug 27, 2004
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
K042005 · NBW
Taidoc Technology Corporation
Chemistry · 32d
Cleared Aug 26, 2004
URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
K040703 · JIO
Dirui Industrial Co., Ltd.
Chemistry · 162d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K041799 · NQD
Ortho-Clinical Diagnostics, Inc.
Chemistry · 54d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1...
K041720 · MRR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 62d
Not Cleared Aug 24, 2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL...
DEN040002 · NQL
Perkinelmer Life Sciences, Inc.
Chemistry · 53d
Cleared Aug 19, 2004
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
K042080 · JJX
Home Diagnostics, Inc.
Chemistry · 16d
Cleared Aug 19, 2004
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K041668 · NQD
Olympus America, Inc.
Chemistry · 62d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL...
K041687 · JJX
Abbott Laboratories
Chemistry · 57d
Cleared Aug 18, 2004
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
K041643 · CEO
Beckman Coulter, Inc.
Chemistry · 62d
Cleared Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · JHI
ACON Laboratories, Inc.
Chemistry · 28d