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
2377–2400 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 04, 1985
ACCESS HEMAWIPE
K843601 · KHE
Medtech Products, Inc.
Hematology · 114d
Cleared Dec 27, 1984
ANTI-LEU-4 FITC LYSIN C BUFFER
K842218 · LIZ
Bd Becton Dickinson Vacutainer...
Hematology · 206d
Cleared Dec 17, 1984
QCA HEMOGLOBIN KIT
K843695 · KRZ
Bd Becton Dickinson Vacutainer...
Hematology · 89d
Cleared Dec 17, 1984
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · JPK
Coulter Electronics, Inc.
Hematology · 81d
Cleared Dec 13, 1984
INRA MENEZO B2 MEDIA
K844288 · KIT
Fcs Laboratories, Inc.
Hematology · 38d
Cleared Dec 12, 1984
HEMOTEC ACT I SYSTEM
K843459 · JBP
Hemotec, Inc.
Hematology · 98d
Cleared Dec 12, 1984
TRI-COUNT LASER
K843485 · JPK
Hematology Marketing Assoc.
Hematology · 97d
Cleared Dec 12, 1984
ORTHO BRAIN THROMBOPLASTIN DILUENT
K843535 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 96d
Cleared Dec 11, 1984
WAKO AUTOMATED REAGENTS FOR HITACHI 705
K842847 · CJW
Wako Chemicals USA, Inc.
Hematology · 144d
Cleared Dec 10, 1984
ABL300 ACID BASE LABORATORY
K844295 · CHL
Radiometer America, Inc.
Hematology · 34d
Cleared Dec 05, 1984
COULTER COUNTER MODEL M4
K843303 · GKL
Coulter Electronics, Inc.
Hematology · 104d
Cleared Dec 05, 1984
COLOSCREEN SELF-TEST
K843352 · KHE
Helena Laboratories
Hematology · 100d
Cleared Nov 30, 1984
COUNT-A-PART PLUS
K841809 · JPK
Diagnostic Technology, Inc.
Hematology · 213d
Cleared Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
K843201 · KFF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
HEPARIN CALIBRATOR ACA
K843202 · KFF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
CAPILLARY BLOOD COLLECTION TUBE
K843608 · GIO
Medical Technomics, Ltd.
Hematology · 78d
Cleared Nov 19, 1984
FACTOR IX DEFICIENT PLASMA, B9D -
K843215 · GGP
Sigma Chemical Co.
Hematology · 96d
Cleared Nov 19, 1984
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
K843310 · GGP
Sigma Chemical Co.
Hematology · 88d
Cleared Nov 19, 1984
FACTOR XI DEFICIENT PLASMA B11D
K843438 · GGP
Sigma Chemical Co.
Hematology · 76d
Cleared Nov 19, 1984
FACTOR XII DEFICIENT PLASMA B12D
K843451 · GGP
Sigma Chemical Co.
Hematology · 75d
Cleared Nov 13, 1984
COULTER COUNTER MODEL ZM
K843164 · GKL
Coulter Electronics, Inc.
Hematology · 92d
Cleared Nov 13, 1984
MICRO HEMATOCRIT CAPILLARY TUBES
K843892 · GIO
Abco Dealers, Inc.
Hematology · 41d
Cleared Nov 01, 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · JPK
R&D Systems, Inc.
Hematology · 21d
Cleared Oct 31, 1984
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
K843360 · CBT
Analytical Products, Inc.
Hematology · 64d