FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
2785–2808 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 02, 1981
LABCER FIBRINOGEN ASSAY KIT & CALIBR.
K812570 · KQJ
Sherwood Medical Co.
Hematology · 23d
Cleared Sep 29, 1981
PLATELET AGITATOR
K812533 · KSQ
Helmer Labs, Inc.
Hematology · 27d
Cleared Sep 29, 1981
TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
K812558 · IDO
Miles Laboratories, Inc.
Hematology · 21d
Cleared Sep 24, 1981
CELL-CHEX RBC
K811741 · KRX
Streck Laboratories, Inc.
Hematology · 97d
Cleared Sep 24, 1981
LOW FIBRINOGEN CONTROL
K812108 · KQJ
Bio/Data Corp.
Hematology · 59d
Cleared Sep 23, 1981
BLOOD FREEZING BAG
K810500 · KSR
Delmed, Inc.
Hematology · 211d
Cleared Sep 23, 1981
ALPHA PLASTIC PLASMA BOTTLE
K810897 · KSR
Alpha Therapeutic Corp.
Hematology · 173d
Cleared Sep 23, 1981
BECKMAN R.PR CONTROL SERUM SET
K812425 · GMP
Beckman Instruments, Inc.
Hematology · 30d
Cleared Sep 23, 1981
FACTOR VIII DEFICIENT PLASMA #B8D
K812431 · GGP
Sigma Chemical Co.
Hematology · 29d
Cleared Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · LCP
Ortho Diagnostic Systems, Inc.
Hematology · 104d
Cleared Sep 16, 1981
MICROCOIL 150 DIALYZER
K811974 · FHS
Erika, Inc.
Hematology · 65d
Cleared Sep 16, 1981
LKB-BROMMA 2188 ULTROTOME NOVA
K812158 · IDM
Lkb Instruments, Inc.
Hematology · 49d
Cleared Sep 16, 1981
CIRCULATING CYTO-THERMS
K812311 · KZL
Cryosan, Inc.
Hematology · 30d
Cleared Sep 11, 1981
STORZ/OLYMPUS MICROSCOPE SYSTEM
K812234 · EPT
Storz Instrument Co.
Hematology · 31d
Cleared Sep 09, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · JPK
American Dade
Hematology · 29d
Cleared Sep 09, 1981
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
K812242 · LCP
Cordis Corp.
Hematology · 29d
Cleared Sep 09, 1981
HEMATOLOGY CONTROL
K812280 · JPK
American Dade
Hematology · 27d
Cleared Sep 09, 1981
IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2
K812355 · CAC
Intl. Business Machines
Hematology · 21d
Cleared Sep 01, 1981
ANTITHROMBIN III SCREEN KIT
K812215 · JBQ
Pacific Hemostasis
Hematology · 27d
Cleared Sep 01, 1981
HELENA HBF QUIPLATE CONTROL
K812226 · KQI
Helena Laboratories
Hematology · 22d
Cleared Aug 25, 1981
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127 · GKR
King Diagnostics, Inc.
Hematology · 29d
Cleared Aug 18, 1981
HEMASPINNER
K811534 · GKJ
Geometric Data, Div. Smithkline Corp.
Hematology · 78d
Cleared Aug 18, 1981
HELENA SICKLE-THAL QUIK COLUMN METHOD
K812077 · JPD
Helena Laboratories
Hematology · 27d
Cleared Aug 18, 1981
LKB-BROMMA 2218 HISTORANGE MICROTOME
K812157 · IDO
Lkb Instruments, Inc.
Hematology · 20d