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
289–312 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 03, 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · GGN
Medtronic, Inc.
Hematology · 23d
Cleared Dec 01, 2010
HEPARIN ASSAY CONTROLS
K103313 · GGN
Medtronic, Inc.
Hematology · 21d
Cleared Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
K093626 · DAP
Siemens Healthcare Diagnostics
Hematology · 370d
Cleared Nov 18, 2010
COULTER 4C-EX 300 CELL CONTROL
K100607 · JPK
Beckman Coulter, Inc.
Hematology · 260d
Cleared Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · JOX
Medtronic, Inc.
Hematology · 31d
Cleared Oct 26, 2010
DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI...
K100489 · GKZ
Beckman Coulter Cellular
Hematology · 249d
Cleared Oct 18, 2010
IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
K101911 · NID
Cylex, Inc.
Hematology · 101d
Cleared Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · JOX
Medtronic, Inc.
Hematology · 160d
Cleared Oct 01, 2010
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
K101831 · OSL
Bionostics, Inc.
Hematology · 92d
Cleared Aug 31, 2010
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
K091539 · GKL
Iris Diagnostics
Hematology · 462d
Cleared Aug 26, 2010
CELLTRACKS AUTOPREP SYSTEM MODEL:9541
K100684 · GKH
Veridex, LLC
Hematology · 169d
Cleared Aug 23, 2010
CELL-CHEX
K101335 · GLQ
Streck
Hematology · 103d
Cleared Aug 02, 2010
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
K091303 · JPK
Bio-Rad Laboratories
Hematology · 455d
Cleared Aug 02, 2010
STA-HYBRID HEP CALIBRATOR
K092937 · JIT
Diagnostica Stago, Inc.
Hematology · 312d
Cleared Jul 28, 2010
ADVIA 2120/2120I BODY FLUIDS
K090346 · GKZ
Siemens Healthcare Diagnostics
Hematology · 532d
Cleared Jul 19, 2010
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
K100031 · KHE
Ind Diagnostic, Inc.
Hematology · 194d
Cleared Jul 01, 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · KHE
Princeton BioMeditech Corp.
Hematology · 104d
Cleared Jun 25, 2010
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
K083878 · GIR
R2 Diagnostics, Inc.
Hematology · 543d
Cleared Jun 11, 2010
INRATIO/INRATIO2 TEST STRIPS
K092987 · GJS
Biosite Incorporated
Hematology · 256d
Cleared May 12, 2010
EASYCELL CELL LOCATOR
K092116 · JOY
Medica Corp.
Hematology · 302d
Cleared May 04, 2010
SPERMCHECK FERTILITY
K100341 · POV
Princeton BioMeditech Corp.
Hematology · 88d
Cleared Apr 28, 2010
ILLUMINA BEADXPRESS SYSTEM
K093128 · NSU
Illumina, Inc.
Hematology · 208d
Cleared Apr 08, 2010
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE,...
K093394 · GKZ
Shenzhen Mindray Bio-Medical...
Hematology · 160d
Cleared Apr 07, 2010
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
K093243 · GJS
Coagusense, Inc.
Hematology · 174d