FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
1849–1872 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
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
Cleared Sep 05, 1989
THROMBIN TIME REAGENT
K894467 · GJA
Sigma Chemical Co.
Hematology · 49d
Cleared Aug 15, 1989
COULTER CLONE MO2
K884605 · GKZ
Coulter Immunology
Hematology · 285d
Cleared Aug 15, 1989
HGB-CAL SET/MULTIPLE
K893984 · KRZ
R&D Systems, Inc.
Hematology · 71d