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
433–456 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 04, 2007
IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
K062755 · JOY
Ikonisys, Inc.
Hematology · 112d
Cleared Dec 14, 2006
E-CHECK (XE)
K063218 · JPK
Streck
Hematology · 51d
Cleared Dec 06, 2006
STA - STACLOT DRVV SCREEN
K061805 · GIR
Diagnostica Stago, Inc.
Hematology · 162d
Cleared Oct 19, 2006
BELMONT BUDDY PLUS FLUID WARMER
K062774 · BSB
Belmont Instrument Corp.
Hematology · 31d
Cleared Oct 06, 2006
ACCESS EPO ASSAY
K052223 · GGT
Beckman Coulter, Inc.
Hematology · 417d
Cleared Oct 04, 2006
COULTER LH 780 HEMATOLOGY ANALYZER
K061616 · GKZ
Beckman Coulter, Inc.
Hematology · 118d
Cleared Sep 18, 2006
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953 · KHE
Yd Diagnostics Corp.
Hematology · 165d
Cleared Sep 14, 2006
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960
K062087 · GKZ
Bd Biosciences
Hematology · 52d
Cleared Sep 01, 2006
HEMOSIL PROTEIN C
K062430 · GGP
Instrumentation Laboratory CO
Hematology · 11d
Cleared Sep 01, 2006
HEMOSIL LIQUID ANTITHROMBIN
K062431 · JBQ
Instrumentation Laboratory CO
Hematology · 11d
Cleared Aug 15, 2006
CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
K060423 · GKZ
Dakocytomation California, Inc.
Hematology · 179d
Cleared Aug 11, 2006
COAGUCHEK XS SYSTEM
K060978 · GJS
Roche Diagnostics
Hematology · 123d
Cleared Aug 01, 2006
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
K061392 · JOY
Ikonisys, Inc.
Hematology · 74d
Cleared Jul 28, 2006
STA - CONTROL LA 1+2
K061803 · GGC
Diagnostica Stago, Inc.
Hematology · 31d
Cleared Jul 21, 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · JOZ
Dade Behring, Inc.
Hematology · 147d
Cleared Jul 21, 2006
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K061574 · GKZ
Beckman Coulter, Inc.
Hematology · 44d
Cleared Jul 14, 2006
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT,...
K061065 · KHE
Teco Diagnostics
Hematology · 88d
Cleared Jul 10, 2006
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · JPK
R&D Systems, Inc.
Hematology · 39d
Cleared Jul 10, 2006
CELL-DYN RUBY SYSTEM
K061667 · GKZ
Abbott Laboratories
Hematology · 26d
Cleared Jul 06, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
K061150 · GKZ
Sysmex America, Inc.
Hematology · 72d
Cleared Jun 30, 2006
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID...
K053571 · JBD
Interlab S.R.L.
Hematology · 190d
Cleared Jun 27, 2006
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
K052291 · GKA
Sebia
Hematology · 308d
Cleared Jun 08, 2006
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
K061047 · GKR
Hemocue AB
Hematology · 55d
Cleared Jun 06, 2006
BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
K060375 · GKZ
Bd Biosciences
Hematology · 113d