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
889–912 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · LCP
Abbott Laboratories
Hematology · 187d
Cleared Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704 · GGP
Instrumentation Laboratory CO
Hematology · 81d
Cleared Oct 15, 1999
ABX PENTRA 60 HEMATOLOGY ANALYZER
K992511 · GKZ
Abx Diagnostics
Hematology · 80d
Cleared Sep 24, 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · GKZ
Abbott Laboratories
Hematology · 64d
Cleared Sep 23, 1999
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
K992849 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 30d
Cleared Sep 21, 1999
ACID HEMOGLOBIN KIT
K992199 · JBD
Helena Laboratories
Hematology · 83d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992423 · GKP
Dade Behring, Inc.
Hematology · 62d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763 · GKP
Dade Behring, Inc.
Hematology · 35d
Cleared Sep 17, 1999
CALTAG FETAL HEMOGLOBIN TEST
K990641 · GHQ
Caltag Laboratories, Inc.
Hematology · 203d
Cleared Sep 17, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · GKP
Dade Behring, Inc.
Hematology · 67d
Cleared Sep 09, 1999
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT...
K991986 · CAC
Cobe Cardiovascular, Inc.
Hematology · 87d
Cleared Sep 03, 1999
PRISMATHERM II, ASTOLINE
K991159 · BSB
Stihler Electronic GmbH
Hematology · 149d
Cleared Sep 03, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130 · KQG
Pacific Hemostasis
Hematology · 72d
Cleared Sep 02, 1999
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160 · BSB
Stihler Electronic GmbH
Hematology · 148d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 1
K992278 · GGN
Pacific Hemostasis
Hematology · 50d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 2
K992279 · GGN
Pacific Hemostasis
Hematology · 50d
Cleared Aug 11, 1999
ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
K991839 · GKZ
Abx Diagnostics
Hematology · 75d
Cleared Jul 28, 1999
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · JOY
Chroma Vision Medical Systems, Inc.
Hematology · 247d
Cleared Jul 28, 1999
DADE BEHRING BFTII
K984501 · JPA
Dade Behring, Inc.
Hematology · 222d
Cleared Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
K990580 · GIR
Precision Biologic
Hematology · 155d
Cleared Jul 26, 1999
CARESIDE PT
K991065 · GJS
Careside, Inc.
Hematology · 117d
Cleared Jul 23, 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
K990579 · GIR
Precision Biologic
Hematology · 150d
Cleared Jul 12, 1999
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203 · GGT
Diagnostic Products Corp.
Hematology · 301d
Cleared Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...
K991605 · GKZ
Abbott Laboratories
Hematology · 60d