FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
409–432 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 27, 2020
Proov Test
K191462 · QKE
Mfb Fertility, Inc.
Chemistry · 269d
Cleared Feb 18, 2020
InPen Dose Calculator
K190487 · NDC
Companion Medical, Inc.
Chemistry · 355d
Cleared Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · NBW
Lifescan Europe GmbH
Chemistry · 60d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
K193103 · NQL
Perkinelmer, Inc.
Chemistry · 91d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 05, 2020
OptiScanner® 5000 Glucose Monitoring System
K192785 · LZF
Optiscan Biomedical Corporation
Chemistry · 128d
Cleared Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · QDK
Dexcom, Inc.
Chemistry · 30d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW
I-Sens, Inc.
Chemistry · 112d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · NBW
I-Sens, Inc.
Chemistry · 25d
Cleared Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
K192547 · DHA
Shenzhen New Industries Biomedical...
Chemistry · 122d
Cleared Jan 14, 2020
Oragene®•Dx
K192920 · OYJ
DNA Genotek, Inc.
Chemistry · 90d
Cleared Dec 20, 2019
ACTIVE® Free Testosterone RIA
K191350 · CDZ
Immunotech S.R.O.
Chemistry · 214d
Cleared Dec 19, 2019
Albumin BCP
K193001 · CJW
SENTINEL CH. SpA
Chemistry · 52d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW
I-Sens, Inc.
Chemistry · 120d
Not Cleared Dec 13, 2019
Control-IQ Technology
DEN190034 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 151d
Not Cleared Dec 12, 2019
GSP Neonatal Creatine Kinase - MM kit
DEN180056 · QJE
Perkinelmer, Inc.
Chemistry · 427d
Cleared Dec 11, 2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test...
K193132 · LCX
Hangzhou Clongene Biotech Co., Ltd.
Chemistry · 29d
Cleared Nov 25, 2019
ADVIA Centaur Cortisol (COR)
K192788 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2019
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test...
K192843 · LCX
Innovita (Tangshan) Biological...
Chemistry · 50d
Cleared Nov 08, 2019
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood...
K191286 · NBW
Ascensia Diabetes Care
Chemistry · 179d