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
673–696 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 11, 2002
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · GKL
Bayer Diagnostics Corp.
Hematology · 55d
Cleared Sep 11, 2002
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS...
K022528 · GKZ
Iq Corp.
Hematology · 42d
Cleared Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...
K021162 · JPA
Sigma Diagnostics, Inc.
Hematology · 141d
Cleared Aug 27, 2002
PROTEIN S AC
K022290 · GGP
Dade Behring, Inc.
Hematology · 43d
Cleared Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · JBQ
Instrumentation Laboratory CO
Hematology · 25d
Cleared Aug 23, 2002
ENOXAPARIN TEST CARD
K013305 · KFF
Cardiovascular Diagnostics, Inc.
Hematology · 323d
Cleared Aug 14, 2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710 · GKR
Biotest Medizintechnik GmbH
Hematology · 162d
Cleared Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET...
K021902 · JQC
Medtronic Vascular
Hematology · 63d
Cleared Aug 07, 2002
MDA D-DIMER
K021877 · GHH
bioMerieux, Inc.
Hematology · 61d
Cleared Aug 07, 2002
COAMATIC AT-400
K022195 · JBQ
Instrumentation Laboratory CO
Hematology · 33d
Cleared Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · GKZ
Beckman Coulter, Inc.
Hematology · 26d
Cleared Jul 29, 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
K022200 · GKZ
Abx Diagnostics
Hematology · 24d
Cleared Jul 23, 2002
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG...
K022046 · GGN
Vital Scientific N.V.
Hematology · 29d
Cleared Jul 17, 2002
BAYER RAPIDPOINT 405 SYSTEM
K020616 · GKR
Bayer Diagnostics Corp.
Hematology · 142d
Cleared Jul 12, 2002
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
K021927 · LXG
Biomet, Inc.
Hematology · 30d
Cleared Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · GKP
Dade Behring, Inc.
Hematology · 93d
Cleared Jun 25, 2002
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
K021241 · GKZ
Sysmex Corporation of America
Hematology · 67d
Cleared Jun 25, 2002
MODIFICATION TO PARA 5X
K021922 · JPK
Streck Laboratories, Inc.
Hematology · 14d
Cleared Jun 24, 2002
MEDICA EASYQC HEMATOCRIT CONTROL
K021924 · GLK
Bionostics, Inc.
Hematology · 13d
Cleared Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · KHE
Alfa Scientific Designs, Inc.
Hematology · 45d
Cleared Jun 14, 2002
HEMOGLOBIN A1C CONTROL
K021484 · LCP
Canterbury Scientific , Ltd.
Hematology · 37d
Cleared Jun 13, 2002
DEROYAL SURGICAL, UMBILICUP
K020753 · KSR
Deroyal
Hematology · 98d
Cleared Jun 12, 2002
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
K012701 · JOZ
Accumetrics, Inc.
Hematology · 302d
Cleared Jun 11, 2002
COULTER CELLPREP
K021150 · GKH
Beckman Coulter, Inc.
Hematology · 62d