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
2785–2808 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · DKZ
Dade Behring, Inc.
Chemistry · 78d
Cleared Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264 · JIX
Roche Diagnostics Corp.
Chemistry · 58d
Cleared Mar 29, 2004
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K040535 · JJY
Cliniqa Corporation
Chemistry · 27d
Cleared Mar 25, 2004
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND...
K040670 · NBW
Home Diagnostics, Inc.
Chemistry · 10d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · NBW
Abbott Laboratories
Chemistry · 15d
Cleared Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN...
K040226 · JIT
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · JIX
Roche Diagnostics Corp.
Chemistry · 50d
Cleared Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
K040181 · JKC
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Mar 24, 2004
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND...
K032657 · NBW
Home Diagnostics, Inc.
Chemistry · 209d
Cleared Mar 18, 2004
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · CIG
Clinical Data, Inc.
Chemistry · 8d
Cleared Mar 18, 2004
ZAP HCG TEST, MODEL 8001
K033297 · JHI
Zbx Corporation
Chemistry · 156d
Cleared Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
K040351 · JJX
Randox Laboratories, Ltd.
Chemistry · 29d
Cleared Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL...
K032936 · JIX
Stanbio Laboratory
Chemistry · 172d
Cleared Mar 11, 2004
VITALAB AMYLASE REAGENT
K040534 · JFJ
Clinical Data, Inc.
Chemistry · 9d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280 · JJY
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Mar 10, 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
K040471 · JIT
Olympus America, Inc.
Chemistry · 15d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 34d
Cleared Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · JJX
R&D Systems, Inc.
Chemistry · 71d
Cleared Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000 · CDT
Clinical Data, Inc.
Chemistry · 77d
Cleared Mar 10, 2004
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 83d
Cleared Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · LBS
Stanbio Laboratory
Chemistry · 170d
Cleared Mar 08, 2004
VITALAB MAGNESIUM REAGENT
K040508 · JGJ
Clinical Data, Inc.
Chemistry · 10d
Cleared Mar 08, 2004
VITALAB URIC ACID REAGENT
K040467 · KNK
Clinical Data, Inc.
Chemistry · 13d
Cleared Mar 08, 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · LCX
Unipath , Ltd.
Chemistry · 25d