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
1681–1704 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777 · GGN
Helena Laboratories
Hematology · 142d
Cleared Aug 22, 1991
SPECTROLYSE PLASMINOGEN SK KIT
K912025 · GGP
Biopool AB
Hematology · 107d
Cleared Aug 22, 1991
ARACHIDONIC ACID
K912774 · JBX
Helena Laboratories
Hematology · 59d
Cleared Aug 16, 1991
PACKS-4 (TM) ANALYZER
K912201 · JBY
Helena Laboratories
Hematology · 88d
Cleared Aug 09, 1991
SIMPLATE PEDIATRIC
K911745 · JCA
Organon Teknika Corp.
Hematology · 113d
Cleared Aug 09, 1991
ACS LIQUID THROMBOPLASTIN
K912102 · GJS
Analytical Control Systems, Inc.
Hematology · 88d
Cleared Jul 26, 1991
SYSMEX F-810
K910849 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 26, 1991
SYSMEX F-610
K911172 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 26, 1991
SYSMEX F-310
K911173 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 24, 1991
HEPARIN ADSORBENT
K912061 · JPA
Sigma Diagnostics, Inc.
Hematology · 76d
Cleared Jul 17, 1991
HEPCON HMS WITH BODY SURFACE AREA CALCULATION
K911240 · JOX
Hemotech, Inc.
Hematology · 118d
Cleared Jul 17, 1991
HEMOCHRON(R) APTT, MODIFICATION
K911994 · GFO
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
K911995 · GJS
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996 · JCA
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
TENDERFOOT(R), MODIFICATION
K911997 · FMK
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
PX COULTER(R) CELL CONTROL
K912133 · JPK
Coulter Electronics, Inc.
Hematology · 64d
Cleared Jul 11, 1991
HEMOGLOBIN REAGENT
K910745 · GKR
Toa Medical Electronics USA, Inc.
Hematology · 140d
Cleared Jul 09, 1991
ABL520 BLOOD GAS SYSTEM
K910827 · GHS
Radiometer America, Inc.
Hematology · 132d
Cleared Jul 09, 1991
COULTERCLONE
K911793 · GKZ
Coulter Immunology
Hematology · 78d
Cleared Jul 09, 1991
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · KRX
R&D Systems, Inc.
Hematology · 42d
Cleared Jul 03, 1991
COLOCARE
K905798 · KHE
Helena Laboratories
Hematology · 226d
Cleared Jul 03, 1991
COLOSCREEN
K911075 · KHE
Helena Laboratories
Hematology · 114d
Cleared Jun 25, 1991
DELFIA(R) 17 -OH-PROGESTERON KIT
K912026 · JLX
Pharmacia Diagnostics, Inc.
Hematology · 49d
Cleared Jun 17, 1991
COULTER(R) MH010
K911385 · GKZ
Coulter Electronics, Inc.
Hematology · 81d