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
1249–1272 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 24, 2012
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · LCX
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 396d
Cleared Sep 21, 2012
DIAZYME HSCRP POC TEST KIT
K121558 · DCK
Diazyme Laboratories
Chemistry · 115d
Cleared Sep 20, 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · JJY
Randox Laboratories, Ltd.
Chemistry · 276d
Cleared Sep 19, 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224 · LFR
Taidoc Technology Corporation
Chemistry · 152d
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 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