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
457–480 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 06, 2006
HEMA SCREEN SPECIFIC IFOBT
K060463 · KHE
Immunostics Inc.,
Hematology · 104d
Cleared Jun 02, 2006
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · JPK
R&D Systems, Inc.
Hematology · 22d
Cleared May 24, 2006
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
K050367 · KFF
Hyphen Biomed
Hematology · 464d
Cleared May 17, 2006
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
K061064 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared May 10, 2006
CRYOCHECK CLOT APCR
K060284 · GGW
Precision Biologic, Inc.
Hematology · 96d
Cleared May 10, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
K060656 · GKZ
Sysmex America, Inc.
Hematology · 58d
Cleared May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
K061014 · JPA
Helena Laboratories
Hematology · 27d
Cleared May 04, 2006
STA-CEPHASCREEN KIT
K053111 · GFO
Diagnostica Stago, Inc.
Hematology · 181d
Cleared May 04, 2006
INSURE II
K060930 · KHE
Enterix, Inc.
Hematology · 29d
Cleared May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
K060931 · GJS
Instrumentation Laboratory CO
Hematology · 27d
Cleared Apr 14, 2006
GUAVA EZCD4 SYSTEM
K053497 · GKZ
Guava Technologies, Inc.
Hematology · 120d
Cleared Apr 13, 2006
HEMOSIL SYNTHASIL
K060688 · GFO
Instrumentation Laboratory CO
Hematology · 29d
Cleared Mar 28, 2006
COULTER 5C CELL CONTROL
K060464 · JPK
Beckman Coulter, Inc.
Hematology · 34d
Cleared Mar 16, 2006
IMMOCARE
K052598 · KHE
Care Diagnostic, Inc.
Hematology · 176d
Cleared Mar 08, 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400,...
K050709 · GKA
Wallac OY
Hematology · 355d
Cleared Feb 21, 2006
ACL ELITE
K060162 · JPA
Instrumentation Laboratory CO
Hematology · 29d
Cleared Feb 09, 2006
NRBC-CHEX FOR LH
K060083 · GJR
Streck
Hematology · 29d
Cleared Jan 24, 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577 · JOY
Ikonisys, Inc.
Hematology · 127d
Cleared Jan 20, 2006
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
K052825 · GGP
Affinity Biologicals, Inc.
Hematology · 107d
Cleared Jan 20, 2006
PF4 ENHANCED SOLID PHASE ELISA
K053559 · LCO
Genetic Testing Institute
Hematology · 30d
Cleared Jan 13, 2006
CELL-CHEX AUTO
K053362 · JPK
Streck
Hematology · 42d
Cleared Jan 13, 2006
HEMOSIL PROS
K053499 · GGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Jan 04, 2006
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
K052697 · GGN
Akers Biosciences, Inc.
Hematology · 98d
Cleared Jan 04, 2006
SMARTPREP2 CENTRIFUGE SYSTEM
K052925 · JQC
Harvest Technologies, Corp.
Hematology · 78d