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
313–336 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 30, 2010
SYSMEX MODEL XT-4000I
K091313 · GKZ
Sysmex America, Inc.
Hematology · 330d
Cleared Mar 23, 2010
ROTEM DELTA THROMBOELASTOMETRY SYSTEM
K083842 · JPA
Pentapharm GmbH
Hematology · 454d
Cleared Mar 18, 2010
COAGUCHEK XS PRO SYSTEM
K093460 · GJS
Roche Diagnostics
Hematology · 132d
Cleared Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
K092940 · GJS
Roche Diagnostics Corp.
Hematology · 162d
Cleared Feb 22, 2010
CAPILLARYS NEONAT HB (PN 2006)
K091283 · GKA
Sebia
Hematology · 297d
Cleared Feb 05, 2010
HEMOSIL D-DIMER HS 500, CONTROLS
K090264 · DAP
Instrumentation Laboratory CO
Hematology · 367d
Cleared Jan 29, 2010
R & D SYSTEMS XERET HEMATOLOGY CONTROL
K100050 · JPK
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 21, 2010
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
K093972 · JKA
Becton, Dickinson & CO
Hematology · 28d
Cleared Jan 08, 2010
OC-SENSOR DIANA IFOB TEST
K092330 · OOX
Polymedco Cancer Diagnostics, LLC
Hematology · 157d
Cleared Dec 22, 2009
STA LIATEST FREE PS
K092170 · GGP
Diagnostica Stago, Inc.
Hematology · 154d
Cleared Dec 22, 2009
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K093167 · JPA
Diagnostica Stago, Inc.
Hematology · 76d
Cleared Dec 18, 2009
STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC...
K093001 · JPA
Diagnostica Stago, Incorporated
Hematology · 81d
Cleared Nov 20, 2009
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
K092868 · JOY
CellaVision AB
Hematology · 63d
Cleared Nov 13, 2009
STA - FREE PS CALIBRATOR
K092113 · JIX
Diagnostica Stago, Inc.
Hematology · 122d
Cleared Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
K091916 · DAP
Siemens Healthcare Diagnostics
Hematology · 121d
Cleared Oct 28, 2009
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL...
K091284 · GGN
Affinity Biologicals, Inc.
Hematology · 180d
Cleared Oct 28, 2009
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
K091433 · JPK
R&D Systems, Inc.
Hematology · 168d
Cleared Oct 09, 2009
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
K090563 · GGN
Instrumentation Laboratory CO
Hematology · 221d
Cleared Sep 22, 2009
ACL TOP 700 LAS
K091980 · GKP
Instrumentation Laboratory CO
Hematology · 83d
Cleared Sep 18, 2009
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K090810 · GKZ
Microgenics Corp.
Hematology · 177d
Cleared Jul 31, 2009
BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
K090967 · GKZ
Bd Biosciences
Hematology · 116d
Cleared Jul 02, 2009
DESTINY MAX COAGULATION ANALYZER
K083896 · JPA
Trinity Biotech
Hematology · 185d
Cleared Jun 10, 2009
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
K090093 · GKR
Stanbio Laboratory
Hematology · 147d
Cleared Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · KFF
Instrumentation Laboratory CO
Hematology · 125d