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
217–240 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 12, 2014
POOL NORM
K142132 · GGN
Diagnostics Stago S.A.S.
Hematology · 130d
Cleared Dec 05, 2014
SYSMEX XN SERIES
K141681 · GKZ
Sysmex America, Inc.
Hematology · 165d
Cleared Dec 05, 2014
XN CAL PF
K141955 · KRX
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK BF
K141957 · JPK
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CAL
K141962 · KRX
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK
K141964 · JPK
Streck
Hematology · 140d
Cleared Sep 05, 2014
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER...
K140911 · GKZ
Beckman Coulter, Inc.
Hematology · 149d
Cleared CT Sep 03, 2014
STA LIATEST D-DI
K141144 · DAP
Diagnostica-Stago
Hematology · 124d
Cleared Aug 15, 2014
HEMOSIL D-DIMER HS 500 CONTROL
K133582 · GGN
Instrumentation Laboratory
Hematology · 267d
Cleared May 02, 2014
I-CHROMA IFOB WITH I-CHROMA READER
K132167 · OOX
Boditech Med, Inc.
Hematology · 294d
Cleared Mar 13, 2014
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
K133005 · GGP
Instrumentation Laboratory CO
Hematology · 169d
Cleared Jan 22, 2014
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
K132722 · GJS
Instrumentation Laboratory CO
Hematology · 145d
Cleared Jan 10, 2014
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
K132076 · GIR
Dsrv, Inc.
Hematology · 191d
Cleared Jan 10, 2014
REAGENT, RUSSEL VIPER VENOM - LA SCREEN
K132130 · GIR
Dsrv, Inc.
Hematology · 184d
Cleared Dec 20, 2013
AGGREGUIDE
K122162 · JOZ
Aggredyne, Inc.
Hematology · 518d
Cleared Sep 18, 2013
NAVIOS FLOW CYTOMETER SYSTEM
K130373 · OYE
Beckman Coulter, Inc.
Hematology · 216d
Cleared Aug 05, 2013
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · GKR
ACON Laboratories, Inc.
Hematology · 349d
Cleared Jul 26, 2013
TETRACHROME REAGENTS AND TETRACXP SYSTEM
K121445 · OYE
Beckman Coulter, Inc.
Hematology · 437d
Cleared Jul 24, 2013
R&D 5D RETIC HEMATOLOGY CONTROL
K130962 · JPK
R&D Systems, Inc.
Hematology · 107d
Cleared Jul 03, 2013
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE...
K120977 · GGN
International Technidyne Corp.
Hematology · 457d
Cleared May 31, 2013
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900 · GGN
Cliniqa Corporation
Hematology · 431d
Cleared May 10, 2013
EUROTROL HEMATOCRIT CONTROL
K121467 · GLK
Eurotrol B.V.
Hematology · 358d
Cleared Mar 24, 2013
HEMOSIL READIPLAS TIN
K122584 · GJS
Instrumentation Laboratory CO
Hematology · 212d
Cleared Mar 22, 2013
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K120771 · GKZ
Beckman Coulter, Inc.
Hematology · 373d