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
2425–2448 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 06, 1984
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · JBQ
Instrumentation Laboratory CO
Hematology · 132d
Cleared Sep 06, 1984
HEMATOLOGY ANALYZER
K842310 · JKL
Hml Inc/Biotechnology Transfer
Hematology · 86d
Cleared Sep 06, 1984
DILU-MATIC 140
K842446 · GKH
Abbott Diagnostics
Hematology · 77d
Cleared Sep 05, 1984
COLOTRAK OCCULT BLOOD TEST
K840527 · KHE
Breit Laboratories, Inc.
Hematology · 211d
Cleared Sep 05, 1984
AUTOLYZER 800
K841852 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 125d
Cleared Sep 05, 1984
OCCULT BLOOD TEST
K842137 · KHE
Breit Laboratories, Inc.
Hematology · 98d
Cleared Aug 17, 1984
HYCEL ROTOR-MIXER AND/OR MULTI
K842746 · KSQ
R&D Systems, Inc.
Hematology · 35d
Cleared Aug 16, 1984
ACCU-CULT FECAL OCCULT BLOOD TEST
K840904 · KHE
Applied Medical Devices, Inc.
Hematology · 170d
Cleared Aug 16, 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140 · GKL
Diagnostic Technology, Inc.
Hematology · 78d
Cleared Aug 15, 1984
GIEMSA STAIN
K842742 · HYF
E K Ind., Inc.
Hematology · 33d
Cleared Aug 14, 1984
CLEAR POROUS PLASTIC-HYPOALLERGENIC
K840948 · GKX
Gainor Medical
Hematology · 39d
Cleared Aug 12, 1984
NEW METHYLENE BLUE N
K842743 · KFC
E K Ind., Inc.
Hematology · 30d
Cleared Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
K840903 · KHE
Helena Laboratories
Hematology · 164d
Cleared Aug 09, 1984
SICKLE-HEME A/S HETEROZYGOUS CONTROL
K842955 · GHM
Michclone Associates, Inc.
Hematology · 13d
Cleared Aug 03, 1984
SALINE, 0.85%W/PRESERVATIVE
K842725 · KIP
E K Ind., Inc.
Hematology · 21d
Cleared Aug 03, 1984
DECOLORIZING FLUID
K842729 · PPM
E K Ind., Inc.
Hematology · 21d
Cleared Aug 02, 1984
EARLY DETECTOR
K833369 · KHE
Warner-Lambert Co.
Hematology · 310d
Cleared Jul 27, 1984
PARA-TEK
K841531 · JPK
Streck Laboratories, Inc.
Hematology · 102d
Cleared Jul 27, 1984
MIDAS II AUTOMATIC STAINER
K842077 · KPA
Innovative Medical Systems, Inc.
Hematology · 65d
Cleared Jul 27, 1984
TECHNICON TEST POINT ASSAYED HEMATOLOGY
K842109 · JPK
Technicon Instruments Corp.
Hematology · 59d
Cleared Jul 27, 1984
HISTOPAQUE-1077
K842146 · JCF
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · GKL
Coulter Electronics, Inc.
Hematology · 43d
Cleared Jul 27, 1984
TECHNICON H*1 SYSTEM
K842636 · GKZ
Technicon Instruments Corp.
Hematology · 18d
Cleared Jul 20, 1984
SICKLE CELL REAGENT SET
K842368 · GHM
Livonia Diagnostics, Inc.
Hematology · 35d