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
2281–2304 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 05, 1985
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
K853239 · KFF
Haemachem, Inc.
Hematology · 96d
Cleared Nov 05, 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
K853328 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 89d
Cleared Nov 05, 1985
COULTER COUNTER MODEL T-660
K854114 · GKL
Coulter Electronics, Inc.
Hematology · 28d
Cleared Nov 05, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · KHG
Eastman Kodak Company
Hematology · 26d
Cleared Oct 31, 1985
THROMBO SCREEN SICKLE CELL ASSAY SET
K854079 · GHM
Pacific Hemostasis
Hematology · 24d
Cleared Oct 31, 1985
MICRO-MAT SYSTEM
K854121 · GKJ
Prevo Micro-Mat System
Hematology · 22d
Cleared Oct 10, 1985
FDP ASSAY-20 TEST KIT
K852848 · GHH
American Bioproducts Co.
Hematology · 97d
Cleared Oct 10, 1985
PARA CHECK (AKA EIGHT CHECK-C)
K852992 · JPK
Streck Laboratories, Inc.
Hematology · 87d
Cleared Oct 10, 1985
COULTER COUNTER MODEL M5
K853429 · GKL
Coulter Electronics, Inc.
Hematology · 56d
Cleared Oct 10, 1985
CITREX H
K853897 · GGW
Bio/Data Corp.
Hematology · 20d
Cleared Oct 04, 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · GHH
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 109d
Cleared Oct 04, 1985
ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
K853198 · JPA
Medical Device Consultants, Inc.
Hematology · 66d
Cleared Oct 04, 1985
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
K853789 · JPA
Hemotec, Inc.
Hematology · 24d
Cleared Sep 30, 1985
LODE COAGULOMETER MODEL LC-6
K852450 · JPA
Lode Corp.
Hematology · 112d
Cleared Sep 19, 1985
MSI-HB HEMOGLOBIN CONTROL
K853776 · JPK
Medical Specialties, Inc.
Hematology · 9d
Cleared Sep 17, 1985
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · GKZ
Abbott Diagnostics
Hematology · 105d
Cleared Sep 17, 1985
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512 · GHH
Pacific Hemostasis
Hematology · 97d
Cleared Sep 03, 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · JPK
Abbott Diagnostics
Hematology · 91d
Cleared Aug 30, 1985
COULTER VOLUME ADAPTER
K851943 · GKL
Coulter Electronics, Inc.
Hematology · 119d
Cleared Aug 29, 1985
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · GGP
American Dade
Hematology · 10d
Cleared Aug 29, 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · GGP
American Dade
Hematology · 10d
Cleared Aug 19, 1985
GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN
K852986 · LCP
Clinical Technology Corp.
Hematology · 35d
Cleared Aug 13, 1985
COAGULATOR
K852492 · KQG
Med USA
Hematology · 62d
Cleared Aug 13, 1985
GENERAL DIAGNOSTICS COAG-A-MATE XC
K852843 · KQC
Warner-Lambert Co.
Hematology · 39d