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
2089–2112 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386 · JCN
R&D Systems, Inc.
Hematology · 65d
Cleared Dec 03, 1987
STACHROM VIII:C TEST KIT
K874097 · GGP
American Bioproducts Co.
Hematology · 56d
Cleared Nov 25, 1987
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 71d
Cleared Nov 23, 1987
REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
K873832 · KRZ
In Vitro Diagnostics, Inc.
Hematology · 63d
Cleared Nov 20, 1987
PLATELET EXTRACT REAGENT
K873382 · GGW
Bio/Data Corp.
Hematology · 88d
Cleared Nov 20, 1987
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · JJQ
Helena Laboratories
Hematology · 88d
Cleared Nov 06, 1987
DIGICELL 500
K873252 · GKL
Contraves Medical Instruments, Inc.
Hematology · 81d
Cleared Nov 06, 1987
MICRO-COUNT DIFFHE
K873256 · GKZ
Toni Diagnostics, Inc.
Hematology · 84d
Cleared Nov 06, 1987
DIGICELL 300 SYSTEM
K873271 · GKL
Contraves Medical Instruments, Inc.
Hematology · 81d
Cleared Nov 04, 1987
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
K873185 · JCF
Dynal Biotech, Inc.
Hematology · 84d
Cleared Nov 04, 1987
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
K873730 · JMG
Medix Biotech, Inc.
Hematology · 50d
Cleared Nov 04, 1987
FALSE RAGWEED ALLERGEN DISC
K874149 · DHB
Incstar Corp.
Hematology · 22d
Cleared Oct 20, 1987
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K873647 · GIO
Ventrex Laboratories, Inc.
Hematology · 41d
Cleared Oct 20, 1987
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
K874054 · GGK
Fisher Scientific Co., LLC
Hematology · 15d
Cleared Oct 02, 1987
LEUCOPREP BRAND TUBE
K872775 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 80d
Cleared Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 117d
Cleared Sep 29, 1987
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K872852 · LCP
Sandare Chemical Co., Inc.
Hematology · 71d
Cleared Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
K873354 · JPK
R&D Systems, Inc.
Hematology · 40d
Cleared Sep 23, 1987
TURBOX
K873401 · JZW
Unipath , Ltd.
Hematology · 30d
Cleared Sep 15, 1987
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
K872230 · DBT
Intermedics, Inc.
Hematology · 98d
Cleared Sep 14, 1987
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · KPA
Fisher Scientific Co., LLC
Hematology · 52d
Cleared Sep 11, 1987
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
K873304 · LJX
Miles Laboratories, Inc.
Hematology · 24d
Cleared Sep 09, 1987
NAPSAC(TM)
K871830 · GKL
Beecher Medical Diagnostic...
Hematology · 121d
Cleared Sep 09, 1987
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · GIF
Abbott Diagnostics
Hematology · 20d