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
97–120 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 28, 2020
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality...
K202089 · POV
Bonraybio Co., Ltd.
Hematology · 92d
Cleared Oct 23, 2020
Cryocheck Hex LA
K193556 · GFO
Precision Biologic
Hematology · 305d
Cleared Oct 16, 2020
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · JOY
CellaVision AB
Hematology · 224d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · JOY
Scopio Labs , Ltd.
Hematology · 140d
Not Cleared Sep 17, 2020
HemosIL Liquid Anti-Xa
DEN190032 · QLU
Instrumentation Laboratory CO
Hematology · 450d
Cleared Sep 11, 2020
PF4 Enhanced assay
K201570 · LCO
Immucor Gti Diagnostics, Inc.
Hematology · 92d
Cleared Aug 21, 2020
Quantra QPlus System
K201513 · QFR
Hemosonics, LLC
Hematology · 74d
Cleared Aug 19, 2020
HemosIL von Willebrand Factor Antigen
K200033 · GGP
Instrumentation Laboratory CO
Hematology · 225d
Cleared Aug 13, 2020
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944 · PTA
Ancestry Genomics, Inc.
Hematology · 300d
Cleared Aug 04, 2020
HemoCue Hb 301 System
K201217 · GKR
Hemocue AB
Hematology · 90d
Cleared Jul 17, 2020
Cryocheck Chromogenic Factor VIII
K193204 · GGP
Precision Biologic
Hematology · 240d
Cleared Jun 18, 2020
PF4 IgG assay
K201311 · LCO
Immucor Gti Diagnostics, Inc.
Hematology · 31d
Cleared Jun 12, 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · GKR
Ekf Diagnostic GmbH
Hematology · 67d
Cleared Apr 16, 2020
Unicel DxH 800 Coulter Cellular Analysis System
K193124 · GKZ
Beckman Coulter
Hematology · 156d
Cleared Feb 28, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680 · JPI
Abbott Point of Care, Inc.
Hematology · 427d
Cleared CT Feb 14, 2020
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for...
K191364 · JOZ
Fujimori Kogyo, Co., Ltd.
Hematology · 268d
Cleared Jan 02, 2020
OC-Auto SENSOR io iFOB Test
K191147 · OOX
Eiken Chemical Co., Ltd.
Hematology · 247d
Cleared Nov 22, 2019
Hemochron Signature Elite
K193041 · JPA
Accriva Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2019
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842 · GGM
Eurotrol B.V.
Hematology · 43d
Cleared CT Nov 01, 2019
Sight OLO
K190898 · GKZ
Sight Diagnostics , Ltd.
Hematology · 210d
Cleared Aug 21, 2019
QNext and DG-PT
K183390 · JPA
Diagnostic Grifols, S.A.
Hematology · 258d
Cleared Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
K183088 · GGT
Axis-Shield Diagnostics Limited
Hematology · 269d
Cleared Jun 27, 2019
SwimCount Sperm Quality Test
K183602 · POV
Motilitycount Aps
Hematology · 183d
Cleared May 30, 2019
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC...
K183205 · JQC
Emcyte Corporation
Hematology · 192d