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
913–936 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 01, 1999
THERMAL ANGEL
K984640 · BSB
Estill Medical Technologies, Inc.
Hematology · 182d
Cleared Jul 01, 1999
EXCELL 22
K991539 · GKZ
Mwi, Inc.
Hematology · 59d
Cleared Jun 23, 1999
CELL-DYN 1200 SYSTEM
K991142 · GKZ
Abbott Laboratories
Hematology · 79d
Cleared Jun 21, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · KQG
Pacific Hemostasis
Hematology · 63d
Cleared Jun 21, 1999
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15...
K991362 · JBD
Morax
Hematology · 68d
Cleared Jun 21, 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE...
K991402 · GKZ
Dako Corp.
Hematology · 60d
Cleared Jun 21, 1999
MOUSE IGG1 NEGATIVE CONTROLS
K991454 · GKZ
Dako Corp.
Hematology · 56d
Cleared Jun 17, 1999
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Jun 10, 1999
VARIANT II B-THALASSEMIA
K991127 · JPD
Bio-Rad
Hematology · 69d
Cleared Jun 07, 1999
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
K990814 · GJT
Precision Biologic
Hematology · 88d
Cleared Jun 01, 1999
COAG-A-MATE MAX
K991101 · GKP
Organon Teknika Corp.
Hematology · 61d
Cleared May 28, 1999
GBACT + KIT
K984141 · JBP
Sienco, Inc.
Hematology · 191d
Cleared May 28, 1999
SMARTPREP CENTRIFUGE SYSTEM
K991430 · JQC
Harvest Technologies, LLC
Hematology · 32d
Cleared May 27, 1999
CRIT-SCAN II MONITOR
K983551 · GKF
In-Line Diagnostics Corp.
Hematology · 230d
Cleared May 14, 1999
TAS ANALYZER, MODEL 1009
K990566 · JPA
Cardiovascular Diagnostics, Inc.
Hematology · 81d
Cleared May 11, 1999
DBEST OCCULT BLOOD TEST KIT
K984269 · KHE
Ameritek, Inc.
Hematology · 201d
Cleared May 11, 1999
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
K990957 · JBL
Astoria-Pacific, Inc.
Hematology · 50d
Cleared May 11, 1999
COULTER Z2 ANALYZER
K991070 · GKL
Coulter Corp.
Hematology · 41d
Cleared May 03, 1999
HEMOCHRON RESPONSE
K983475 · KQG
International Technidyne Corp.
Hematology · 213d
Cleared Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
K990327 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858 · GGN
Bio-Rad
Hematology · 37d
Cleared Apr 13, 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT...
K983892 · JPA
Roche Diagnostics/Boehringer Mannheim...
Hematology · 161d
Cleared Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT...
K990172 · GKZ
Coulter Corp.
Hematology · 84d
Cleared Apr 13, 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · JPA
International Technidyne Corp.
Hematology · 60d