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
2233–2256 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 14, 1986
DISPETTE II
K860899 · JPH
Ulster Scientific, Inc.
Hematology · 35d
Cleared Apr 11, 1986
SICKLE CELL REAGENT SET
K860812 · GHM
Michclone Associates, Inc.
Hematology · 38d
Cleared Apr 07, 1986
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K860028 · KHE
Self Care Systems, Inc.
Hematology · 94d
Cleared Apr 04, 1986
VES-TEC/VES-MATIC
K854223 · CKB
Marvic Interpharma, Inc.
Hematology · 168d
Cleared Apr 04, 1986
DIGITAL-9 KEY LEUCOCYTE COUNTER
K854685 · GKM
Future Impex Corp.
Hematology · 135d
Cleared Apr 04, 1986
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
K860122 · JBP
Medical Device Consultants, Inc.
Hematology · 80d
Cleared Apr 04, 1986
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
K860166 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared Apr 04, 1986
ASSERACHROM VWF KIT
K860371 · GGP
American Bioproducts Co.
Hematology · 60d
Cleared Mar 18, 1986
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K860751 · JPK
Bio/Data Corp.
Hematology · 18d
Cleared Mar 12, 1986
HEMATOLOGY CALIBRATOR CONTROL
K854166 · KRZ
Interscience Diagnostics, Inc.
Hematology · 148d
Cleared Mar 12, 1986
COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
K854938 · JPA
Diatech, Inc.
Hematology · 92d
Cleared Mar 06, 1986
FS TEST KIT
K854015 · JBN
American Bioproducts Co.
Hematology · 160d
Cleared Mar 06, 1986
BT-795/P AUTOMATED AUTOTRANS
K860306 · CAC
Electromedics, Inc.
Hematology · 37d
Cleared Mar 04, 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · JPA
Bio/Data Corp.
Hematology · 34d
Cleared Mar 03, 1986
HEPANORM CALIBRATION PLASMA SET
K854762 · KFF
American Bioproducts Co.
Hematology · 96d
Cleared Mar 03, 1986
HEMOGLOBIN REAGENT SET
K860475 · KHG
Sterling Diagnostics, Inc.
Hematology · 24d
Cleared Feb 26, 1986
COATEST PLASMINOGEN
K854572 · DDX
Kabivitrum, Inc.
Hematology · 104d
Cleared Feb 24, 1986
ERMA PC-604 BLOOD CELL COUNTER
K854677 · GKL
Future Impex Corp.
Hematology · 96d
Cleared Feb 24, 1986
ERMA PC-602 PC-603 BLOOD CELL COUNTER
K854678 · GKL
Future Impex Corp.
Hematology · 81d
Cleared Feb 24, 1986
SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM
K855116 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 63d
Cleared Feb 24, 1986
SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM
K855117 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 63d
Cleared Feb 24, 1986
SICKLE CELL REAGENT SET
K860420 · GHM
Sterling Diagnostics, Inc.
Hematology · 20d
Cleared Feb 13, 1986
CBC-CAL/MULTIPLE
K854823 · KSA
R&D Systems, Inc.
Hematology · 72d
Cleared Feb 11, 1986
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945 · CDD
Ciba Corning Diagnostics Corp.
Hematology · 63d