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
1921–1944 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 10, 1989
DADE THROMBOPLASTIN IS
K891169 · GJS
Baxter Healthcare Corp
Hematology · 35d
Cleared Apr 10, 1989
EDL ABNORMAL COAGULATION CONTROL
K891175 · GGL
Elite Diagnostic , Ltd.
Hematology · 35d
Cleared Apr 10, 1989
EDL NORMAL COAGULATION CONTROL
K891179 · GIZ
Elite Diagnostic , Ltd.
Hematology · 35d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · GHH
Abbott Laboratories
Hematology · 60d
Cleared Mar 23, 1989
NE-CHECK
K890767 · JPK
Streck Laboratories, Inc.
Hematology · 36d
Cleared Mar 21, 1989
HEMATASTAT H-70
K890849 · GKG
Separation Technology, Inc.
Hematology · 28d
Cleared Mar 15, 1989
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K890619 · GFO
Elite Diagnostic , Ltd.
Hematology · 36d
Cleared Mar 13, 1989
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940 · GGP
American Diagnostic Corp.
Hematology · 105d
Cleared Mar 13, 1989
ACTICLOT C KIT
K884941 · GGP
American Diagnostic Corp.
Hematology · 105d
Cleared Mar 03, 1989
AGEN DIMERTEST EIA
K890189 · DAP
Agen Biomedical , Ltd.
Hematology · 45d
Cleared Feb 28, 1989
NEVISCAN MODEL N - 100
K884989 · HKI
Special Products, Inc.
Hematology · 89d
Cleared Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409 · GGP
Baxter Healthcare Corp
Hematology · 34d
Cleared Feb 27, 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 24, 1989
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227 · KHG
Heraeus Kulzer, Inc.
Hematology · 66d
Cleared Feb 24, 1989
BIOTRACK APTT REAGENT CARTRIDGE
K890052 · GFO
Biotrack, Inc.
Hematology · 49d
Cleared Feb 23, 1989
BIOTRACK APTT CONTROLS
K890051 · GIT
Biotrack, Inc.
Hematology · 48d
Cleared Feb 22, 1989
COULTER FLOW RETICULOCYTE REAGENT
K885332 · GKL
Coulter Electronics, Inc.
Hematology · 56d
Cleared Feb 17, 1989
HEMA(PRO)TEC(TION)
K885324 · GIO
Medical Products Search, Inc.
Hematology · 51d
Cleared Feb 16, 1989
COULTER 5P CONTROL
K885028 · GKZ
Coulter Electronics, Inc.
Hematology · 73d
Cleared Feb 15, 1989
CTS-3060 AUTOMATED SEMEN ANALYZER
K881765 · POV
Motion Analysis Corp.
Hematology · 296d
Cleared Feb 10, 1989
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE
K890503 · GKB
Gespac, Inc.
Hematology · 9d
Cleared Feb 07, 1989
CAPILLARY TUBE, BLOOD COLLECTION
K885138 · GIO
Coeur Laboratories, Inc.
Hematology · 54d
Cleared Feb 07, 1989
MODIFIED D-DI-TEST KIT
K890399 · GHH
American Bioproducts Co.
Hematology · 14d
Cleared Feb 03, 1989
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · GKZ
Coulter Immunology
Hematology · 157d