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
2329–2352 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 05, 1985
DASS PACK
K851280 · GIF
Dass, Inc.
Hematology · 95d
Cleared Jul 05, 1985
SDI PREPAX DILUKIT M.
K851320 · GIF
Scientific Distributors, Inc.
Hematology · 94d
Cleared Jul 05, 1985
SICKLE-CHEX
K852107
Streck Laboratories, Inc.
Hematology · 51d
Cleared Jul 05, 1985
GLYCO-CHECK
K852111 · LCP
Thyroid Diagnostics, Inc.
Hematology · 51d
Cleared Jul 05, 1985
PRECINORM HB
K852136 · GGM
Boehringer Mannheim Corp.
Hematology · 50d
Cleared Jul 05, 1985
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · GKH
Abbott Diagnostics
Hematology · 31d
Cleared Jun 17, 1985
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431 · KHE
Nms Pharmaceuticals, Inc.
Hematology · 133d
Cleared Jun 12, 1985
AGGRO/LINK COMPUTER INTERFACE
K851025 · JBX
Chrono-Log Corp.
Hematology · 93d
Cleared May 29, 1985
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
K851125 · GJS
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126 · GGW
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
K851127 · JPA
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 23, 1985
METACHROME
K851174 · LNJ
Potomac Medical System
Hematology · 59d
Cleared May 20, 1985
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS
K850354 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 110d
Cleared May 15, 1985
MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &
K851737 · KIT
Sigma
Hematology · 20d
Cleared May 15, 1985
MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &
K851738 · KIT
Sigma
Hematology · 20d
Cleared May 13, 1985
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
K850171 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 117d
Cleared May 13, 1985
PLATELET AGGREGATION REAGENT
K850592 · JBX
Chrono-Log Corp.
Hematology · 87d
Cleared May 13, 1985
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · JPK
R&D Systems, Inc.
Hematology · 77d
Cleared May 10, 1985
PLASMA EXTRACTION SYSTEM
K850391 · JPI
Hans J. Brouwers & Assoc.
Hematology · 98d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · JPA
Warner-Lambert Co.
Hematology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · JBQ
Warner-Lambert Co.
Hematology · 93d
Cleared May 08, 1985
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · KFF
Warner-Lambert Co.
Hematology · 90d
Cleared May 02, 1985
SYSTEM 8000 CELL COUNTER
K850386 · GKL
Baker Instructions Corp.
Hematology · 90d
Cleared Apr 12, 1985
HFF GENCELLS
K850990 · KIT
Bioassay Systems Research Corp.
Hematology · 32d