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
2809–2832 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 08, 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · LCX
Unipath , Ltd.
Chemistry · 26d
Cleared Mar 05, 2004
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
K040455 · JJX
Cliniqa Corporation
Chemistry · 11d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Mar 04, 2004
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K033060 · JIT
Diamond Diagnostics, Inc.
Chemistry · 157d
Cleared Mar 02, 2004
A1C-CELLULAR
K040025 · JJX
Streck Laboratories, Inc.
Chemistry · 55d
Cleared Mar 02, 2004
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K),...
K033851 · JIL
Hypoguard USA, Inc.
Chemistry · 82d
Cleared Feb 27, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND...
K033786 · JIT
Ibl GmbH
Chemistry · 85d
Cleared Feb 27, 2004
RANDOX URIC ACID
K033278 · CDO
Randox Laboratories, Ltd.
Chemistry · 140d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157 · JJX
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Feb 23, 2004
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K040091 · JJY
Cliniqa Corporation
Chemistry · 38d
Cleared Feb 20, 2004
AXSYM CORTISOL ASSAY
K033731 · JFT
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · JIX
Bayer Healthcare, LLC
Chemistry · 71d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426 · CEW
DiaSorin, Inc.
Chemistry · 108d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844 · MRG
DiaSorin, Inc.
Chemistry · 154d
Cleared Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · LCP
Seradyn, Inc.
Chemistry · 77d
Cleared Feb 05, 2004
MODIFICATION TO DIADEXUS PLAC TEST
K040101 · NOE
Diadexus, Inc.
Chemistry · 16d
Cleared Feb 04, 2004
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706 · LPS
Polymedco, Inc.
Chemistry · 70d
Cleared Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 47d
Cleared Feb 02, 2004
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
K030849 · JJX
N-Dia, Inc.
Chemistry · 322d
Cleared Jan 30, 2004
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · JGJ
Abaxis, Inc.
Chemistry · 10d
Cleared Jan 30, 2004
OLYMPUS URINE CALIBRATOR
K033910 · JIX
Cliniqa Corporation
Chemistry · 44d
Cleared Jan 30, 2004
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME...
K033606 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 74d
Cleared Jan 30, 2004
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033058 · CGX
Diamond Diagnostics, Inc.
Chemistry · 123d
Cleared Jan 30, 2004
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
K033056 · CDS
Diamond Diagnostics, Inc.
Chemistry · 123d