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
1321–1344 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared May 10, 1995
HEPARIN MANAGEMENT TEST CARD
K943283 · KFF
Cardiovascular Diagnostics, Inc.
Hematology · 307d
Cleared May 05, 1995
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · GKZ
Immunotech Corp.
Hematology · 84d
Cleared May 02, 1995
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K935598 · GIL
Clinical Controls, Inc.
Hematology · 529d
Cleared Apr 28, 1995
HEMOCHRON HNPT/FACTOR VI PT+
K945078 · GJS
International Technidyne Corp.
Hematology · 193d
Cleared Apr 26, 1995
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
K932530 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 708d
Cleared Apr 26, 1995
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
K932531 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 708d
Cleared Apr 26, 1995
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
K932532 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 708d
Cleared Apr 26, 1995
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 511d
Cleared Apr 26, 1995
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
K941713 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 419d
Cleared Apr 25, 1995
EZ-RANGE
K941965 · JPK
Hematronix, Inc.
Hematology · 368d
Cleared Apr 18, 1995
BEHRING FIBRINTIMER A
K926551 · JPA
Behring Diagnostics, Inc.
Hematology · 838d
Cleared Apr 17, 1995
N/T PROTEIN CONTROL PY
K951012 · GIL
Behring Diagnostics, Inc.
Hematology · 42d
Cleared Apr 14, 1995
VARIANT TOTAL GHB PROGRAM
K941616 · LCP
Bio-Rad
Hematology · 375d
Cleared Apr 07, 1995
AT-III CALIBRATOR
K944279 · JBQ
American Bioproducts Co.
Hematology · 220d
Cleared Apr 05, 1995
HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES
K936056 · KHE
Dipro Diagnostic Products GmbH
Hematology · 471d
Cleared Apr 05, 1995
DV TEST AND DVV CONFIRM
K940490 · GIR
American Diagnostica, Inc.
Hematology · 426d
Cleared Mar 24, 1995
TOA MEDICAL ELECTRONICS CA-1000
K942096 · JPA
Sysmex Corp.
Hematology · 344d
Cleared Mar 24, 1995
TOA MEDICAL ELECTRONICS CA-5000
K942097 · JPA
Sysmex Corp.
Hematology · 344d
Cleared Mar 24, 1995
MICROSAMPLE COAGULATION ANALYZER
K943153 · GKP
Bio/Data Corp.
Hematology · 267d
Cleared Mar 24, 1995
HEPARIN ASSAY CARTRIDGES AND CONTROLS
K944115 · GFT
Medtronic Hemotec, Inc.
Hematology · 213d
Cleared Mar 21, 1995
PTT-LT TEST KIT
K941210 · GGW
American Bioproducts Co.
Hematology · 372d
Cleared Mar 21, 1995
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · GGN
American Bioproducts Co.
Hematology · 243d
Cleared Mar 15, 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · GGN
International Technidyne Corp.
Hematology · 173d
Cleared Mar 14, 1995
CRIT-LINE HEMATOCRIT ALERT
K950942 · JPI
In-Line Diagnostics Corp.
Hematology · 27d