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
817–840 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 21, 2000
CARESIDE HEMOGLOBIN
K001462 · KHG
Careside, Inc.
Hematology · 103d
Cleared Aug 21, 2000
SYSMEX R-500
K001683 · GKL
Sysmex Corporation of America
Hematology · 81d
Cleared Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · GKP
Dade Behring, Inc.
Hematology · 66d
Cleared Jul 26, 2000
DRX HBA1C
K000887 · LCP
Metrika, Inc.
Hematology · 128d
Cleared Jul 12, 2000
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891 · GKP
Bio/Data Corp.
Hematology · 21d
Cleared Jun 23, 2000
IL TEST LIQUID ANTITHROMBIN
K994238 · JBQ
Instrumentation Laboratory CO
Hematology · 190d
Cleared Jun 21, 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · JPA
Dade Behring, Inc.
Hematology · 79d
Cleared Jun 20, 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · JPA
Dade Behring, Inc.
Hematology · 78d
Cleared Jun 07, 2000
MDA D-DIMER
K000492 · DAP
Organon Teknika Corp.
Hematology · 113d
Cleared Jun 07, 2000
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
K992799 · GGT
Sangui Biotech, Inc.
Hematology · 293d
Cleared May 26, 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · JPA
Dade Behring, Inc.
Hematology · 60d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · LCP
Abbott Laboratories
Hematology · 339d
Cleared May 24, 2000
CONTROL PLASMA N
K001256 · GIZ
Dade Behring, Inc.
Hematology · 35d
Cleared May 22, 2000
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
K993131 · LCP
Primus, Inc.
Hematology · 245d
Cleared May 19, 2000
KAWASUMI LABORATORY BLOOD DRAWING KIT
K001043 · KSB
Kawasumi Laboratories America, Inc.
Hematology · 49d
Cleared May 18, 2000
STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
K000611 · GKZ
Bd Biosciences
Hematology · 85d
Cleared May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · GKP
Dade Behring, Inc.
Hematology · 31d
Cleared May 05, 2000
SERIM LEUKOCYTE ESTERASE TEST STRIPS
K000578 · LJX
Serim Research Corp.
Hematology · 73d
Cleared May 05, 2000
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
K000897 · GKZ
Bd Biosciences
Hematology · 45d
Cleared May 05, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
K993678 · JPA
Haemoscope Corp.
Hematology · 186d
Cleared Apr 26, 2000
K-ASSAY AT-III
K000361 · JBQ
Kamiya Biomedical Co.
Hematology · 82d
Cleared Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649 · GGP
Dade Behring, Inc.
Hematology · 57d
Cleared Apr 20, 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · GKZ
Coulter Corp.
Hematology · 197d
Cleared Apr 18, 2000
PARA 12 PLUS RETICS
K000945 · GLQ
Streck Laboratories, Inc.
Hematology · 26d