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
3073–3096 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · JHI
Sa Scientific, Inc.
Chemistry · 126d
Cleared Dec 13, 2002
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Dec 11, 2002
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS...
K023928 · JJW
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Dec 11, 2002
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 68d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 09, 2002
WIENER LAB GOT (AST) UV AA LIQUIDA
K023551 · CIT
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
K023550 · KNK
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · JFJ
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
ACCESS TOTAL T4 ASSAY
K023369 · KLI
Beckman Coulter, Inc.
Chemistry · 62d
Cleared Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN,...
K023304 · JKR
Diagnostic Products Corp.
Chemistry · 67d
Cleared Dec 06, 2002
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K023661 · JJY
Cliniqa Corporation
Chemistry · 36d
Cleared Dec 06, 2002
BECTON DICKINSON DIABETES SOFTWARE
K023219 · NBW
Becton, Dickinson & CO
Chemistry · 71d
Cleared Nov 29, 2002
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
K022915 · JXN
Alfa Scientific Designs, Inc.
Chemistry · 87d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883 · JJX
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · LCX
Unipath , Ltd.
Chemistry · 23d
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897 · LCP
Randox Laboratories, Ltd.
Chemistry · 169d
Cleared Nov 25, 2002
BD VACUTAINER SST II PLUS TUBES
K023331 · JKA
Becton, Dickinson & CO
Chemistry · 52d
Cleared Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · JLW
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Nov 25, 2002
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
K023075 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 70d
Cleared Nov 22, 2002
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
K023352 · JJY
Maine Standards Co.
Chemistry · 46d
Cleared Nov 22, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K022746 · CHL
Nova Biomedical Corp.
Chemistry · 95d
Cleared Nov 20, 2002
ASCENSIA DEX 2 DIABETES CARE SYSTEM
K023584 · NBW
Bayer Corp.
Chemistry · 26d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · NBC
Roche Diagnostics Corp.
Chemistry · 112d
Cleared Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K023184 · DIC
Bayer Diagnostics Corp.
Chemistry · 55d