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
2257–2280 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (MPXI)
K853027 · GKZ
Technicon Instruments Corp.
Hematology · 202d
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (HDW)
K853030 · GKL
Technicon Instruments Corp.
Hematology · 202d
Cleared Feb 04, 1986
ASSERACHROM IX:AG
K854312 · GGP
American Bioproducts Co.
Hematology · 99d
Cleared Feb 04, 1986
ASSERACHROM FPA KIT
K854384 · DAN
American Bioproducts Co.
Hematology · 97d
Cleared Jan 24, 1986
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · GKZ
Technicon Instruments Corp.
Hematology · 190d
Cleared Jan 21, 1986
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
K852988 · GKZ
Technicon Instruments Corp.
Hematology · 190d
Cleared Jan 17, 1986
PLT-4 PLATELET ANALYZER
K853722 · GKL
Texas Intl. Laboratories, Inc.
Hematology · 134d
Cleared Jan 07, 1986
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · JPA
Bio/Data Corp.
Hematology · 55d
Cleared Jan 06, 1986
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854089 · JPA
Diatech, Inc.
Hematology · 91d
Cleared Jan 06, 1986
DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854090 · JPA
Diatech, Inc.
Hematology · 91d
Cleared Jan 03, 1986
ASSERA PLATE IX:AG KIT
K854014 · GGP
American Bioproducts Co.
Hematology · 98d
Cleared Jan 03, 1986
ASSERACHROM PROTEIN C KIT
K854016 · JLA
American Bioproducts Co.
Hematology · 98d
Cleared Jan 01, 1986
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 72d
Cleared Jan 01, 1986
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · GKZ
Abbott Diagnostics
Hematology · 64d
Cleared Dec 23, 1985
MICRO-MAT SYSTEM
K854962 · GKJ
Ulster Scientific, Inc.
Hematology · 12d
Cleared Dec 04, 1985
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
K854376 · JPA
Hemotec, Inc.
Hematology · 35d
Cleared Dec 04, 1985
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
K854377 · JOX
Hemotec, Inc.
Hematology · 35d
Cleared Nov 26, 1985
PLATELET-TROL II
K854353 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Nov 12, 1985
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
K852790 · CHL
Nova Biomedical Corp.
Hematology · 134d
Cleared Nov 12, 1985
21 HEMATOLOGY REAGENTS
K853304 · GKZ
In Vitro Diagnostics, Inc.
Hematology · 99d
Cleared Nov 12, 1985
THROMBOPLASTIN-R REAGENT
K853986 · JPA
American Dade
Hematology · 46d
Cleared Nov 12, 1985
LEUCO PREP
K854093 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 36d
Cleared Nov 05, 1985
COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE
K851153 · JPA
Astral Medical Systems
Hematology · 228d
Cleared Nov 05, 1985
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036 · GKL
Diagnostic Technology, Inc.
Hematology · 110d