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
2497–2520 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 16, 2005
URITEK-720+ URINE ANALYZER
K051526 · KQO
Teco Diagnostics
Chemistry · 69d
Cleared Aug 11, 2005
MODIFICATION TO ABL800 FLEX
K050869 · CIG
Radiometer Medical Aps
Chemistry · 127d
Cleared Aug 09, 2005
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K051802 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 35d
Cleared Aug 09, 2005
Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
K050182 · CGA
Biomedix, Inc.
Chemistry · 194d
Cleared Aug 08, 2005
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE...
K051936 · NBW
Taidoc Technology Corporation
Chemistry · 21d
Cleared Aug 08, 2005
DIRECT LDL CHOLESTEROL, MODEL L530-60H
K051121 · MRR
Teco Diagnostics
Chemistry · 98d
Cleared Aug 08, 2005
CRP DIAGNOSTIC ASSAY
K050836 · DCK
Sentinel Ch. Srl
Chemistry · 129d
Cleared Aug 05, 2005
CLEVER CHEK TD-4225, MODEL TD-4225
K051854 · NBW
Taidoc Technology Corporation
Chemistry · 28d
Cleared Aug 04, 2005
IMMUNALYSIS COCAINE ELISA FOR HAIR
K050465 · DIO
Immunalysis Corporation
Chemistry · 154d
Cleared Aug 03, 2005
ABBOTT AXSYM B12
K051327 · CDD
Abbott Laboratories
Chemistry · 75d
Cleared Aug 02, 2005
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
K051285 · CGA
Infopia Co, Ltd.
Chemistry · 77d
Cleared Aug 01, 2005
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · JIX
Bayer Healthcare, LLC
Chemistry · 45d
Cleared Jul 26, 2005
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K051150 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 83d
Cleared Jul 26, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 83d
Cleared Jul 26, 2005
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
K050823 · LBR
Teco Diagnostics
Chemistry · 117d
Cleared Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
K051687 · JJY
Roche Diagnostics Corp.
Chemistry · 32d
Cleared Jul 25, 2005
SENTINEL PLASMAPROTEINS CAL 3X
K051457 · JIX
Sentinel Ch. Srl
Chemistry · 53d
Cleared Jul 25, 2005
SAFETY NEEDLE
K051019 · JKA
Sarstedt, Inc.
Chemistry · 94d
Cleared Jul 22, 2005
AFINION HBALC
K050574 · LCP
Axis-Shield Poc AS
Chemistry · 137d
Cleared Jul 19, 2005
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE...
K051012 · JIT
Salimetrics, LLC
Chemistry · 89d
Cleared Jul 13, 2005
3TEST GLUCOSE MONITORING SYSTEM
K050224 · NBW
Neuero Engineering, Inc.
Chemistry · 163d
Cleared Jul 12, 2005
SIDEKICK BLOOD GLUCOSE TEST SYSTEM
K051147 · NBW
Home Diagnostics, Inc.
Chemistry · 69d
Cleared Jul 12, 2005
RAPID READER
K041696 · DKZ
American Bio Medica Corp.
Chemistry · 385d
Cleared Jul 11, 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · MMI
Roche Diagnostics
Chemistry · 12d