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
1849–1872 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 09, 1989
FIBRINOGEN ASSAY KIT
K896052 · KQJ
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Nov 09, 1989
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
K896092 · GHD
Sigma Chemical Co.
Hematology · 21d
Cleared Nov 09, 1989
PARA TECH FOR TECHNICON H-1
K896154 · JCN
Streck Laboratories, Inc.
Hematology · 16d
Cleared Nov 06, 1989
AVL MODEL 912 CO-OXYLITE
K895466 · GLY
Avl Scientific Corp.
Hematology · 56d
Cleared Oct 27, 1989
FDP COLLECTION TUBES
K896033 · JCO
Medical Diagnostic Technologies, Inc.
Hematology · 11d
Cleared Oct 24, 1989
MODIFIED HEMOGLOBIN REAGENT SET
K894951 · GKK
Macomb Biotechnology, Inc.
Hematology · 96d
Cleared Oct 24, 1989
THROMBELASTOGRAPH(R)
K895844 · GKP
Haemoscope Corp.
Hematology · 21d
Cleared Oct 10, 1989
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
K894943 · GGT
Amgen, Inc.
Hematology · 68d
Cleared Oct 10, 1989
BIOTRACK HEMOGLOBIN TEST CARTRIDGE
K895101 · KHG
Biotrack, Inc.
Hematology · 56d
Cleared Oct 10, 1989
BIOTRACK PDS MONITOR
K895102 · JJQ
Biotrack, Inc.
Hematology · 56d
Cleared Oct 10, 1989
ARGOS
K895127 · GKZ
Abx, Inc.
Hematology · 54d
Cleared Oct 06, 1989
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
K895255 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
K895260 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
K895261 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · GIZ
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
HEMATOLOGY CONTROL
K895373 · JCN
Medical Specialties Intl., Inc.
Hematology · 38d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-VIII
K895503 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-IX
K895504 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Sep 29, 1989
TRU-TRAX
K894851 · GIO
Humagen, Inc.
Hematology · 60d
Cleared Sep 26, 1989
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
K894539 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 68d
Cleared Sep 13, 1989
COULTER POSITIVE CONTROL CELLS
K894651 · GGL
Coulter Corp.
Hematology · 51d
Cleared Sep 05, 1989
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
K894317 · JOX
Hemotec, Inc.
Hematology · 53d
Cleared Sep 05, 1989
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
K894359 · JPA
Hemotec, Inc.
Hematology · 53d
Cleared Sep 05, 1989
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
K894466 · JPA
Hemotec, Inc.
Hematology · 49d