Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1273–1296 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 13, 2012
LABONACHECK A1C
K111128 · LCP
Ceragem International, Inc.
Chemistry · 511d
Cleared Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · LCP
Beckman Coulter, Inc.
Chemistry · 113d
Cleared Sep 11, 2012
TESTOSTERONE TEST SYSTEM
K120009 · CDZ
Abbott Laboratories
Chemistry · 252d
Cleared Sep 07, 2012
HEMOCUE HBA1C 501
K121366 · LCP
Infopia Co, Ltd.
Chemistry · 123d
Cleared Sep 07, 2012
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609 · LBS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 191d
Cleared Sep 05, 2012
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK...
K121654 · CGA
I-Sens, Inc.
Chemistry · 92d
Cleared Sep 05, 2012
TEST, BLOOD GLUCOSE SYSTEM
K120064 · NBW
Hmd Biomedical, Inc.
Chemistry · 240d
Cleared Aug 31, 2012
THERMO SCIENTIFIC MAS OMNI-CARDIO
K122291 · JJY
Microgenics Corporation
Chemistry · 31d
Cleared Aug 31, 2012
FLEXLAB 3.6, ACCELERATOR A3600
K121012 · CEM
Inpeco S.P.A.
Chemistry · 150d
Cleared Aug 30, 2012
SMARTLYTE ELECTROLYTE ANALYZER
K121040 · CEM
Diamond Diagnostics, Inc.
Chemistry · 147d
Cleared Aug 30, 2012
VANTERA CLINICAL ANALYZER
K113830 · CDT
Liposcience
Chemistry · 247d
Cleared Aug 28, 2012
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION...
K122323 · CJO
Siemens Healthcare Diagnostics
Chemistry · 27d
Cleared Aug 27, 2012
ACE MAGNESIUM REGENT
K122302 · JGJ
Alfa Wassermann Diagnostics...
Chemistry · 26d
Cleared Aug 24, 2012
RANDOX OPIATES ASSAY
K113747 · DJG
Randox Laboratories Limited
Chemistry · 248d
Cleared Aug 22, 2012
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083 · JHW
Elitechgroup
Chemistry · 37d
Cleared Aug 22, 2012
PROLYTE ELECTROLYTE ANALYZER
K121140 · JGS
Diamond Diagnostics, Inc.
Chemistry · 128d
Cleared Aug 22, 2012
EON CALCIUM REGENT
K120626 · CJY
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 174d
Cleared CT Aug 21, 2012
CLEVER CHOICE
K120921 · CGA
Simple Diagnostics, Inc.
Chemistry · 147d
Cleared Aug 21, 2012
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE...
K112916 · NBW
Tyson Bioresearch, Inc.
Chemistry · 323d
Cleared Aug 14, 2012
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
K122126 · JIS
Randox Laboratories Limited
Chemistry · 27d
Cleared Aug 10, 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN
Alfa Wassermann Diagnostic...
Chemistry · 268d
Cleared Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
K122141 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 19d
Cleared Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4...
K113437 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 259d
Cleared Aug 03, 2012
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
K120423 · NBW
Bionime Corporation
Chemistry · 172d