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
2353–2376 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 03, 1985
DIMERTEST LATEX
K842277 · GHH
Mabco, Inc.
Hematology · 299d
Cleared Apr 01, 1985
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -
K844910 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 104d
Cleared Apr 01, 1985
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239 · GIF
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Apr 01, 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · JPK
Technicon Instruments Corp.
Hematology · 69d
Cleared Mar 29, 1985
LASER-GLOBIN POWDER
K850094 · GKR
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-DIL
K850095 · GIF
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-GLOBIN
K850096 · GKR
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-LYSE
K850097 · GGK
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
NSI LYSING-D REAGENT -4000 ML
K850944 · GGK
Nobel Scientific Industries, Inc.
Hematology · 22d
Cleared Mar 26, 1985
THROMBINEX BOVINE THROMBIN
K845000 · GJA
Bio/Data Corp.
Hematology · 90d
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · GKL
Abbott Diagnostics
Hematology · 89d
Cleared Mar 25, 1985
CORNING BLOOD COLLECTION CAPILLARY TUBES
K850806 · GIO
Corning Medical & Scientific
Hematology · 26d
Cleared Mar 22, 1985
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
K844897 · JPK
Medical Specialties Laboratories
Hematology · 95d
Cleared Mar 22, 1985
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
K844927 · JPK
Bhp Diagnostix, Inc.
Hematology · 93d
Cleared Mar 22, 1985
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
K844928 · JPK
Bhp Diagnostix, Inc.
Hematology · 93d
Cleared Mar 07, 1985
CYNOMOLGUS MONKEY BLOOD IN ALSEVER'S
K850217 · KIT
Hazleton Research Products, Inc.
Hematology · 44d
Cleared Mar 05, 1985
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 96d
Cleared Mar 05, 1985
TRI-COUNT CALIBRATOR
K844708 · KSA
Hematology Marketing Assoc.
Hematology · 92d
Cleared Mar 05, 1985
NSI ELT-D DILUTING FLUID 4000ML
K844782 · GIF
Nobel Scientific Industries, Inc.
Hematology · 85d
Cleared Mar 01, 1985
SURGICUTT - BLEEDING TIME DEVICE
K850542 · JCA
International Technidyne Corp.
Hematology · 18d
Cleared Feb 27, 1985
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
K850157 · KPA
Shaban Mfg. Co.
Hematology · 43d
Cleared Feb 27, 1985
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
K850333 · KPA
Shaban Mfg. Co.
Hematology · 30d
Cleared Feb 25, 1985
A1 SYSTEME 8201/2
K841803 · GKL
Med USA
Hematology · 300d
Cleared Jan 07, 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
K843910 · KRY
Coulter Electronics, Inc.
Hematology · 96d