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
121–144 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared May 09, 2019
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
K183160 · JPA
Haemonetics Corporation
Hematology · 175d
Cleared Mar 29, 2019
AggreGuide A-100 ADP
K181777 · JOZ
Aggredyne, Inc.
Hematology · 269d
Cleared Mar 15, 2019
CELL-DYN Emerald 22 AL System
K190294 · GKZ
Abbott Laboratories
Hematology · 32d
Cleared Mar 12, 2019
CRYOcheck FVIII Inhibitor Kit
K183440 · GGP
Precision Biologic, Inc.
Hematology · 90d
Not Cleared Mar 12, 2019
Quantra Hemostasis Analyzer, QPlus Cartridge
DEN180017 · QFR
Hemosonics, LLC
Hematology · 344d
Cleared Mar 01, 2019
DxH 520 Hematology Instrument
K181475 · GKZ
Beckman Coulter
Hematology · 270d
Cleared Feb 21, 2019
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
K183255 · GJS
Coagusense, Inc.
Hematology · 92d
Cleared Feb 01, 2019
HemoCue Hb 801 System
K181751 · GKR
Hemocue AB
Hematology · 214d
Cleared Feb 01, 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K182744 · GGM
Eurotrol B.V.
Hematology · 126d
Cleared Jan 25, 2019
microINR System
K180780 · GJS
Iline Microsystems, S.L.
Hematology · 305d
Cleared Jan 25, 2019
MiniCollect K2E K2EDTA Tubes
K182078 · JKA
Greiner Bio-One Na, Inc.
Hematology · 176d
Cleared Jan 25, 2019
Sysmex XN-L Automated Hematology Analyzer
K182389 · GKZ
Sysmex America, Inc.
Hematology · 143d
Cleared Dec 14, 2018
CAPI 3 HEMOGLOBIN(E)
K180762 · GKA
Sebia
Hematology · 266d
Cleared Nov 16, 2018
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
K180343 · POV
Bonraybio Co., Ltd.
Hematology · 282d
Cleared Nov 16, 2018
hemochroma PLUS System
K182298 · GKR
Immunostics Inc.,
Hematology · 84d
Cleared Nov 05, 2018
Athelas One
K181288 · GKZ
Athelas, Inc.
Hematology · 173d
Cleared Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · JOY
Sysmex America, Inc.
Hematology · 90d
Cleared Oct 29, 2018
HemoScreen Hematology Analyzer
K180020 · GKZ
Pixcell Medical Technologies, Ltd.
Hematology · 300d
Cleared Sep 07, 2018
INNOVANCE Free PS Ag
K181525 · GGP
Siemens Healthcare Diagnostics...
Hematology · 88d
Cleared May 09, 2018
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia...
K173202 · JPA
Sekisui Medical Co., Ltd.
Hematology · 219d
Cleared Apr 23, 2018
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
K171883 · LKM
Sysmex America, Inc.
Hematology · 304d
Cleared Apr 19, 2018
CoaguChek XS Plus System
K180684 · GJS
Roche Diagnostics
Hematology · 35d
Cleared Apr 19, 2018
CoaguChek XS Pro System
K180693 · GJS
Roche Diagnostics
Hematology · 34d
Cleared Apr 06, 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · GKR
Ekf Diagnostic GmbH
Hematology · 261d