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
145–168 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 22, 2018
HemosIL Factor XII Deficient Plasma
K180486 · GJT
Instrumentation Laboratory CO
Hematology · 27d
Cleared Mar 02, 2018
cobas m 511 integrated hematology analyzer
K171655 · GKZ
Roche Diagnostics Hematology, Inc.
Hematology · 270d
Cleared Feb 15, 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · KHE
Alfa Scientific Designs, Inc.
Hematology · 136d
Cleared Jan 12, 2018
cobas Factor II and Factor V Test
K172913 · NPR
Roche Molecular Systems, Inc.
Hematology · 109d
Cleared Dec 25, 2017
CoaguChek Vantus System
K170960 · GJS
Roche Diagnostics
Hematology · 269d
Cleared Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
K172286 · JPA
Siemens Healthcare Diagnostic...
Hematology · 143d
Cleared Nov 22, 2017
HemosIL D-Dimer HS 500
K172903 · DAP
Instrumentation Laboratory CO
Hematology · 61d
Cleared Nov 17, 2017
Trak Plus Male Fertility Testing System
K172514 · POV
Sandstone Diagnostics, Inc.
Hematology · 88d
Cleared Nov 06, 2017
XW-100 Automated Hematology Analyzer for CLIA Waived Use
K172604 · GKZ
Sysmex America, Inc.
Hematology · 68d
Cleared Nov 01, 2017
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K170353 · GKZ
HORIBA ABX SAS
Hematology · 271d
Cleared Oct 31, 2017
Sysmex CS-5100
K172333 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared Oct 05, 2017
InSure ONE
K170548 · KHE
Enterix, Inc.
Hematology · 223d
Cleared Sep 13, 2017
AnemoCheck
K163215 · KHG
Sanguina, LLC
Hematology · 301d
Cleared Sep 13, 2017
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview...
K171664 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 100d
Cleared Sep 08, 2017
hemochroma PLUS System
K163465 · GKR
Immunostics Inc.,
Hematology · 270d
Cleared Sep 08, 2017
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854 · LCO
Instrumentation Laboratory CO
Hematology · 170d
Cleared Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r)...
K162540 · KFF
Siemens Healthcare Diagnostics...
Hematology · 344d
Cleared Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · JPI
Abbott Laboratories
Hematology · 266d
Cleared Aug 11, 2017
ADVIA 2120i, ADVIA 2120
K162977 · GKZ
Siemens Healthcare Diagnostics
Hematology · 289d
Cleared Aug 08, 2017
AFIAS iFOB with AFIAS-50
K163225 · OOX
Immunostics Inc.,
Hematology · 264d
Cleared Aug 01, 2017
Advanced RBC Application
K171315 · JOY
CellaVision AB
Hematology · 89d
Cleared Jun 21, 2017
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K170864 · GGN
Maine Standards Company, LLC
Hematology · 90d
Cleared Jun 14, 2017
hema-screen SPECIFIC Gold
K171484 · KHE
Immunostics Inc.,
Hematology · 23d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · KHE
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d