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
577–600 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 10, 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
K040882 · DAP
bioMerieux, Inc.
Hematology · 66d
Cleared Jun 10, 2004
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
K041130 · KRZ
Clinical Diagnostic Solutions, Inc.
Hematology · 41d
Cleared Jun 10, 2004
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234 · GKR
Hemocue, Inc.
Hematology · 31d
Cleared Jun 02, 2004
SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
K041240 · NRF
Fertility Solutions, Inc.
Hematology · 22d
Cleared May 28, 2004
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K040293 · LCO
Akers Laboratories, Inc.
Hematology · 112d
Cleared May 24, 2004
PHOSPHOPLASTIN RL
K040296 · GJS
R2 Diagnostics, Inc.
Hematology · 105d
Cleared May 04, 2004
INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
K040146 · GKA
Interlab S.R.L.
Hematology · 103d
Cleared Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · GGP
Instrumentation Laboratory CO
Hematology · 29d
Cleared Apr 05, 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139 · GGP
Corgenix, Inc.
Hematology · 269d
Cleared Apr 02, 2004
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
K032951 · JOZ
Chrono-Log Corp.
Hematology · 193d
Cleared Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · JPA
Instrumentation Laboratory CO
Hematology · 35d
Cleared Mar 18, 2004
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
K040073 · GKZ
Sysmex America, Inc.
Hematology · 64d
Cleared Mar 12, 2004
IMMUNICON CELLTRACKS AUTOPREP SYSTEM
K040077 · GKH
Immunicon Corp.
Hematology · 58d
Cleared Feb 27, 2004
LYPHOCHEK HEMOSTASIS CONTROL
K040275 · GGN
Bio-Rad
Hematology · 22d
Cleared Feb 13, 2004
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · GJT
Instrumentation Laboratory CO
Hematology · 51d
Cleared Feb 11, 2004
SYSMEX POCH-100I
K032677 · GKL
Sysmex America, Inc.
Hematology · 166d
Cleared Feb 10, 2004
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
K033840 · JOY
CellaVision AB
Hematology · 62d
Cleared Feb 04, 2004
PHOSPHOLIN ES AND CALCIUM CHLORIDE
K033471 · GGW
R2 Diagnostics, Inc.
Hematology · 93d
Cleared Feb 03, 2004
INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
K032862 · JBD
Interlab S.R.L.
Hematology · 144d
Cleared Jan 29, 2004
MEDONIC CA620/530 HEMATOLOGY ANALYZER
K032214 · GKZ
Boule Medical AB
Hematology · 192d
Cleared Jan 12, 2004
ACL TOP MODEL, TOP
K033414 · GKP
Instrumentation Laboratory CO
Hematology · 77d
Cleared Jan 02, 2004
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · JBQ
Instrumentation Laboratory CO
Hematology · 30d
Cleared Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
K033631 · GGP
Instrumentation Laboratory CO
Hematology · 26d
Cleared Dec 12, 2003
AIACT KIT
K032952 · JBP
Sienco, Inc.
Hematology · 81d