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
2305–2328 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 13, 1985
CALCIUM CHLORIDE
K853246 · JPA
Bio/Data Corp.
Hematology · 12d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176 · GHH
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 84d
Cleared Aug 12, 1985
CEPHALINEX ACTIVATED PTT REAGENT
K852195 · GGW
Bio/Data Corp.
Hematology · 84d
Cleared Aug 12, 1985
PLASTINEX
K852484 · GJS
Bio/Data Corp.
Hematology · 62d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
K852519 · JCO
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 56d
Cleared Aug 12, 1985
CITREX I
K853076 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX II
K853077 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX III
K853078 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 08, 1985
UNI-PLATE
K852643
Medical Specialties Laboratories
Hematology · 48d
Cleared Aug 08, 1985
ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
K852834
Ortho Diagnostic Systems, Inc.
Hematology · 37d
Cleared Jul 30, 1985
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · LCP
Bio-Rad
Hematology · 102d
Cleared Jul 30, 1985
COULTER CHANNELYZER 256
K851736 · GKL
Coulter Electronics, Inc.
Hematology · 96d
Cleared Jul 30, 1985
OSMOCEL 3
K851843 · GIF
Hematology Marketing Assoc.
Hematology · 95d
Cleared Jul 23, 1985
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
K851641 · MSJ
Ortho Diagnostic Systems, Inc.
Hematology · 95d
Cleared Jul 23, 1985
QUICK-COUNT HEMATOLOGY CONTROLS
K851663 · JPK
Seragen Diagnostics, Inc.
Hematology · 91d
Cleared Jul 23, 1985
MONITOR IV PLUS
K851669 · JOZ
Helena Laboratories
Hematology · 91d
Cleared Jul 23, 1985
TECHNICON H*1 SYSTEM
K852787
Technicon Instruments Corp.
Hematology · 22d
Cleared Jul 18, 1985
SRT-SYSTEM
K852554 · JPH
Microwave Development, Inc.
Hematology · 31d
Cleared Jul 16, 1985
HEMOGLOBIN ANALYZER
K851467 · KHG
Awareness Technology, Inc.
Hematology · 92d
Cleared Jul 15, 1985
CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
K852516 · JPI
Whittaker General Medical
Hematology · 32d
Cleared Jul 12, 1985
TRI-COUNT
K851375 · JPK
Hematology Marketing Assoc.
Hematology · 95d
Cleared Jul 12, 1985
HEMOGLOBIN
K851432 · KHG
Pointe Scientific, Inc.,
Hematology · 93d
Cleared Jul 09, 1985
CHOLESTEROL TEST SYSTEM
K850390 · CHH
Hans J. Brouwers & Assoc.
Hematology · 158d
Cleared Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
K852016 · KRY
R&D Systems, Inc.
Hematology · 61d