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: Hematology ×
3,297 results
169–192 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 19, 2017
TEG 6s Hemostasis System
K160502 · JPA
Haemonetics Corporation
Hematology · 421d
Not Cleared Apr 06, 2017
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary...
DEN160026 · PTA
23AndMe, Inc.
Hematology · 282d
Cleared Apr 05, 2017
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
K163274 · JOZ
Aggredyne, Inc.
Hematology · 135d
Cleared Mar 16, 2017
VALIDATE Heparin Calibration Verification/Linearity Test Kit
K163498 · GGN
Maine Standards Company, LLC
Hematology · 93d
Cleared Mar 03, 2017
ACL AcuStar
K170314 · JPA
Instrumentation Laboratory CO
Hematology · 30d
Cleared Feb 23, 2017
George King Coumadin Plasma
K161316 · GGN
George King Bio-Medical, Inc.
Hematology · 288d
Cleared Jan 17, 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554 · KHE
Immunostics Inc.,
Hematology · 29d
Cleared Jan 05, 2017
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
K162705 · GGN
Maine Standards Company, LLC
Hematology · 99d
Cleared Dec 26, 2016
Sysmex CS-2100i
K162688 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared Dec 22, 2016
Sysmex XN-L Automated Hematology Analyzer
K160538 · GKZ
Sysmex America, Inc.
Hematology · 300d
Cleared Dec 22, 2016
XN CAL
K160585 · KRX
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN-L CHECK
K160586 · JPK
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK BF
K160588 · JPK
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK
K160590 · JPK
Streck
Hematology · 296d
Cleared Dec 12, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K162420 · JPA
Siemens Healthcare Diagnostics...
Hematology · 104d
Cleared CT Dec 10, 2016
STA® - Liatest® D-Di
K162227 · DAP
Diagnostica-Stago
Hematology · 124d
Cleared Dec 02, 2016
Chrono-log Platelet Aggregometer, 4 channel
K161329 · JOZ
Chrono-Log Corp.
Hematology · 204d
Cleared Nov 29, 2016
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
K162414 · GKZ
Beckman Coulter, Inc.
Hematology · 92d
Cleared Nov 23, 2016
AMICUS Separator System, AMICUS Separator System
K162462 · GKT
Fresenius Kabi USA,Llc
Hematology · 82d
Cleared Nov 08, 2016
YO Home Sperm Test
K161493 · POV
Medical Electronic Systems , Ltd.
Hematology · 160d
Cleared Oct 27, 2016
HemosIL D-Dimer HS
K160885 · DAP
Instrumentation Laboratory CO
Hematology · 210d
Cleared Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · GJS
Siemens Healthcare Diagnostics
Hematology · 442d
Cleared Sep 02, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K161317 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Sep 01, 2016
BC-5390 Auto Hematology Analyzer
K160429 · GKZ
Mindray Bio-Medical Electronics Co.,...
Hematology · 198d