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

1369–1392 of 3,297

Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology

Cleared Nov 21, 1994

MONOCLONAL MOUSE ANTI-HUMAN B-CELL

Hematology · 137d

Cleared Nov 21, 1994

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25

Hematology · 82d

Cleared Nov 10, 1994

MONOCLONAL MOUSE ANTI-HUMAN T-CELL

Hematology · 148d

Cleared Oct 31, 1994

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328

Helena Laboratories

Hematology · 495d

Cleared Oct 27, 1994

GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION

Alicia Diagnostics, Inc.

Hematology · 723d

Cleared Oct 18, 1994

HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM

International Technidyne Corp.

Hematology · 231d

Cleared Oct 13, 1994

AGGRO/LINK VW COFACTOR SOFTWARE

Chrono-Log Corp.

Hematology · 233d

Cleared Oct 11, 1994

TINA-QUANT HEMOGLOBIN A1C

Boehringer Mannheim Corp.

Hematology · 417d

Cleared Oct 07, 1994

SPECIALTY ASSAYED CONTROL-1

Helena Laboratories

Hematology · 183d

Cleared Oct 07, 1994

CBC-LINE HEMATOLOGY LINEARITY CONTROL

R&D Systems, Inc.

Hematology · 114d

Cleared Sep 30, 1994

AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS

Becton Dickinson Immunocytometry Systems

Hematology · 711d

Cleared Sep 20, 1994

MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER

Medtronic Hemotec, Inc.

Hematology · 232d

Cleared Sep 20, 1994

Organon Teknika Corp.

Hematology · 48d

Cleared Sep 19, 1994

DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA

American Diagnostica, Inc.

Hematology · 322d

Cleared Sep 14, 1994

SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)

Helena Laboratories

Hematology · 152d

Cleared Sep 14, 1994

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

Hematology · 142d

Cleared Sep 09, 1994

FASCOUNT SYSTME

Becton Dickinson Immunocytometry Systems

Hematology · 417d

Cleared Sep 08, 1994

LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2

Clinical Controls, Inc.

Hematology · 342d

Cleared Aug 30, 1994

SEMEN ANALYSIS KIT

Humagen Fertility Diagnostics, Inc.

Hematology · 1014d

Cleared Aug 30, 1994

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

Diagnostic Specialties

Hematology · 182d

Cleared Jul 19, 1994

QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)

R&D Systems, Inc.

Hematology · 215d

Cleared Jul 19, 1994

ACT CONTROL SET

Sigma Diagnostics, Inc.

Hematology · 146d

Cleared Jul 19, 1994

AMES DCA 2000 HEMOGLOBIN ALC CONTROLS

Heraeus Kulzer, Inc.

Hematology · 139d

Cleared Jun 30, 1994

CATALOG NO. J-ACT+ & QC-ACT+

International Technidyne Corp.

Hematology · 121d