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
3121–3144 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 08, 2002
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946 · MMI
Princeton BioMeditech Corp.
Chemistry · 34d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · JGS
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Oct 02, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
K022936 · JJY
Cliniqa Corporation
Chemistry · 28d
Cleared Oct 02, 2002
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE
K022885 · JJY
Cliniqa Corporation
Chemistry · 33d
Cleared Oct 02, 2002
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER...
K022867 · JJY
Cliniqa Corporation
Chemistry · 35d
Cleared Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
K022455 · CFE
Helena Laboratories
Chemistry · 67d
Cleared Sep 30, 2002
FASTPACK TESTOSTERONE CALIBRATOR
K022533 · JIT
Qualigen, Inc.
Chemistry · 61d
Cleared Sep 30, 2002
LDL CHOLESTEROL (AUTOMATED)
K022519 · JHM
Jas Diagnostics, Inc.
Chemistry · 62d
Cleared Sep 30, 2002
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
K022409 · JHT
Spectral Diagnostics, Inc.
Chemistry · 68d
Cleared Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
K022901 · JIS
Ortho-Clinical Diagnostics
Chemistry · 24d
Cleared Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
K022851 · JJY
Quidel Corp.
Chemistry · 31d
Cleared Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021814 · MMI
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Sep 24, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · CHH
Polymer Technology Systems, Inc.
Chemistry · 21d
Cleared Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · MRR
Hemagen Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
K022758 · JJX
Cliniqa Corporation
Chemistry · 28d
Cleared Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
K022386 · JIL
Arkray, Inc.
Chemistry · 57d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · CIG
Abbott Laboratories
Chemistry · 57d
Cleared Sep 12, 2002
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724 · NBW
Lifescan, Inc.
Chemistry · 27d
Cleared Sep 11, 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · JKA
Becton, Dickinson & CO
Chemistry · 12d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP...
K022158 · CGA
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Sep 10, 2002
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER...
K021334 · CJY
Wiener Laboratories Saic
Chemistry · 137d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM...
K022182 · NBW
Abbott Laboratories
Chemistry · 68d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · JFT
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · CIG
Abbott Laboratories
Chemistry · 65d