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
193–216 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 01, 2016
BC-5D Hematology Control
K160606 · JPK
R&D Systems, Inc.
Hematology · 183d
Cleared Sep 01, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K161312 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Jul 08, 2016
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
K153137 · LCO
Instrumentation Laboratory CO
Hematology · 252d
Cleared Jun 17, 2016
BinaxNOW G6PD Test
K161364 · JBF
Alere Scarborough, Inc.
Hematology · 31d
Cleared Jun 03, 2016
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
K152961 · GGN
Maine Standards Company, LLC
Hematology · 240d
Cleared May 27, 2016
Glocyte Automated Cell Counter System
K152776 · GKL
Advanced Instruments, Inc.
Hematology · 245d
Cleared May 16, 2016
Trak Male Fertility Testing System
K153683 · POV
Sandstone Diagnostics, Inc.
Hematology · 146d
Cleared Mar 16, 2016
HemosIL Silica Clotting Time
K160445 · GFO
Instrumentation Laboratory CO
Hematology · 28d
Cleared Mar 06, 2016
VisuCon-F Low Fibrinogen Control Plasma
K150144 · GGN
Affinity Biologicals, Inc.
Hematology · 409d
Cleared Mar 03, 2016
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL...
K160276 · GKP
Instrumentation Laboratory CO
Hematology · 30d
Cleared Jan 31, 2016
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme...
K143470 · GIS
Diazyme Laboratories
Hematology · 422d
Cleared Jan 26, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K151259 · JPA
Siemens Healthcare Diagnostics...
Hematology · 259d
Cleared Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · JPA
Siemens Healthcare Diagnostic...
Hematology · 301d
Cleared Dec 13, 2015
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877 · GKP
Instrumentation Laboratory CO
Hematology · 256d
Cleared Dec 09, 2015
PENTRA XLR
K151133 · GKZ
HORIBA ABX SAS
Hematology · 225d
Cleared Oct 12, 2015
XW-100 Automated Hematology Analyzer, XW QC CHECK
K143577 · GKZ
Sysmex America, Inc.
Hematology · 299d
Cleared Aug 21, 2015
BC-3600 Auto Hematology Analyzer
K143348 · GKZ
Mindray Bio-Medical Electronics Co.,...
Hematology · 273d
Cleared Aug 20, 2015
OC-Light S FIT
K143325 · KHE
Eiken Chemical Co., Ltd.
Hematology · 273d
Cleared Aug 07, 2015
STA R MAX
K151867 · JPA
Diagnostica Stago S.A.S
Hematology · 29d
Cleared Jul 24, 2015
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
K141427 · JOZ
Accumetrics, Inc.
Hematology · 420d
Cleared Jul 06, 2015
HemosIL D-Dimer HS
K151534 · DAP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Jun 26, 2015
CORA (Coagulation Resonance Analysis) System
K150041 · JPA
Coramed Technologies, LLC
Hematology · 168d
Cleared Jan 03, 2015
CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
K140893 · JOZ
Coramed Technologies, LLC
Hematology · 270d
Cleared Dec 20, 2014
ABX MICROS ES 60 CT
K141161 · GKZ
HORIBA ABX SAS
Hematology · 229d