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
2425–2448 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 30, 2005
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · MMI
Bayer Healthcare, LLC
Chemistry · 65d
Cleared Dec 29, 2005
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE...
K052115 · DKZ
First Check Diagnostics, LLC
Chemistry · 147d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
K053109 · NQD
Dade Behring, Inc.
Chemistry · 49d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · JIS
Dade Behring, Inc.
Chemistry · 49d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · JMO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 73d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · JIT
Abbott Laboratories
Chemistry · 15d
Cleared Dec 16, 2005
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
K053196 · NJV
Inverness Medical Innovations, Inc.
Chemistry · 30d
Cleared Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090 · JFM
Beckman Coulter, Inc.
Chemistry · 44d
Cleared Dec 16, 2005
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
K052694 · JHI
Ind Diagnostic, Inc.
Chemistry · 79d
Cleared Dec 16, 2005
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
K052007 · CFR
Horiba Abx
Chemistry · 144d
Cleared Dec 15, 2005
I-STAT CREATINE KINASE MB (CK-MB)
K051433 · MYT
I-Stat Corporation
Chemistry · 197d
Cleared Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · JGS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Dec 14, 2005
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · JGS
Teco Diagnostics
Chemistry · 76d
Cleared Dec 14, 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · MMI
Bayer Healthcare, LLC
Chemistry · 92d
Cleared Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · LBS
Dade Behring, Inc.
Chemistry · 25d
Cleared Dec 09, 2005
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804 · DJZ
Omega Point Systems, LLC
Chemistry · 66d
Cleared Dec 09, 2005
GLUCOSE PILOT
K052208 · NBW
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 119d
Cleared Dec 07, 2005
E-SAN BLUETOOTH CRADLE
K052343 · NBW
E-San Limited
Chemistry · 103d
Cleared Dec 07, 2005
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
K052108 · NBW
Sein Electronics Co., Ltd.
Chemistry · 126d
Cleared Dec 07, 2005
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
K051733 · NHG
Drg Intl., Inc.
Chemistry · 162d
Cleared Dec 07, 2005
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
K051714 · KWW
Diazyme Laboratories
Chemistry · 163d
Cleared Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
K051382 · NBC
Roche Diagnostics Corp.
Chemistry · 192d
Cleared Nov 30, 2005
LIBERTY GLUCOSE CONTROL, MODEL 2120031
K052980 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 37d
Cleared Nov 30, 2005
ONE STEP FSH MENOPAUSAL TEST
K052662 · CGJ
Ind Diagnostic, Inc.
Chemistry · 64d