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
1081–1104 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 30, 1997
COULTER ACT TRON CELL CONTROL
K971469 · JPK
Coulter Corp.
Hematology · 69d
Cleared Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · GGN
American Bioproducts Co.
Hematology · 213d
Cleared Jun 26, 1997
STA-LIATEST D-DI TEST KIT
K964728 · DAP
American Bioproducts Co.
Hematology · 213d
Cleared Jun 24, 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14,...
K964974 · GKZ
Dako Corp.
Hematology · 194d
Cleared Jun 17, 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428 · GGN
Pacific Hemostasis
Hematology · 61d
Cleared Jun 17, 1997
DIASCREEN REAGENT STRIPS
K971976 · LJX
Dia-Screen Corp.
Hematology · 19d
Cleared May 30, 1997
MDX 2000, DIGITAL ANALYZER
K970824 · JOY
Shotwell & Carr, Inc.
Hematology · 85d
Cleared May 29, 1997
TAS PT-NCTEST CONTROLS
K971748 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 17d
Cleared May 23, 1997
STA D-DI CALIBRATOR KIT
K964718 · DAP
American Bioproducts Co.
Hematology · 179d
Cleared May 21, 1997
FIF TM
K970189 · KQJ
Panbio, Inc.
Hematology · 120d
Cleared May 19, 1997
BC THROMBIN REAGENT
K970645 · GJA
Behring Diagnostics, Inc.
Hematology · 88d
Cleared May 14, 1997
CALTAG CAL-LYSE
K965232 · GKZ
Caltag Laboratories, Inc.
Hematology · 134d
Cleared May 05, 1997
BEHRING COAGULATION SYSTEM
K970431 · JPA
Behring Diagnostics, Inc.
Hematology · 90d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
K970593 · GJT
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K970607 · GJT
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 22, 1997
COAGUCHEK PST SYSTEM
K962571 · GJS
Boehringer Mannheim Corp.
Hematology · 295d
Cleared Apr 22, 1997
HYDRAGEL 15 HB A1C KIT
K963844 · LCP
Morax
Hematology · 209d
Cleared Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
K951640 · GGP
The Binding Site, Ltd.
Hematology · 742d
Cleared Apr 16, 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · KQJ
Crestat Diagnostics, Inc.
Hematology · 117d
Cleared Apr 16, 1997
CBC-4K HEMATOLOGY CONTROL
K970331 · JPK
R&D Systems, Inc.
Hematology · 78d
Cleared Mar 28, 1997
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
K962687 · JQW
Nichols Institute Diagnostics
Hematology · 260d
Cleared Mar 18, 1997
THROMBONOSTIKA F1.2
K964934 · MIF
Organon Teknika Corp.
Hematology · 99d
Cleared Mar 18, 1997
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · JPA
Sysmex Corp.
Hematology · 98d
Cleared Mar 18, 1997
MDA HEPARIN ANTI-X ASSAY
K965076 · KFF
Organon Teknika Corp.
Hematology · 89d