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
1897–1920 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 22, 1989
APTT BY HEMOCHRON(R)
K892209 · GFO
Intensive Technology, Inc.
Hematology · 80d
Cleared Jun 22, 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · GJS
International Technidyne Corp.
Hematology · 52d
Cleared Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · LCP
Helena Laboratories
Hematology · 54d
Cleared Jun 20, 1989
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 49d
Cleared Jun 16, 1989
PRIMUS MODEL CLC 330
K891235 · LCP
Primus, Inc.
Hematology · 101d
Cleared Jun 13, 1989
DANAM VECTOR-8+
K892205 · GKZ
Danam Electronics
Hematology · 71d
Cleared Jun 07, 1989
HELENA THROMBOPLASTIN REAGENT
K892050 · GJS
Helena Laboratories
Hematology · 70d
Cleared May 26, 1989
LEUCOPREP CELL SEPARATION TUBE
K891407 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 73d
Cleared May 24, 1989
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
K892522 · GKB
Gespac, Inc.
Hematology · 43d
Cleared May 24, 1989
SDI PREPAX COUNTAPETTE KIT
K892658 · JCG
Scientific Distributors, Inc.
Hematology · 41d
Cleared May 22, 1989
COAG-1 APTT TEST CARD
K891015 · GFO
Cardiovascular Diagnostic Services
Hematology · 83d
Cleared May 17, 1989
FETAL HEMOGLOBIN
K892241 · GHQ
Sure-Tech Diagnostic Associates, Inc.
Hematology · 56d
Cleared Apr 21, 1989
BERICHROM ALPHA-2-ANTIPLASMIN
K884797 · GGP
Behring Diagnostics, Inc.
Hematology · 156d
Cleared Apr 21, 1989
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
K890633 · LCO
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Apr 21, 1989
BERICHROM PROTEIN C KIT
K890634 · GGP
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Apr 21, 1989
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
K890859 · GFO
Elite Diagnostic , Ltd.
Hematology · 59d
Cleared Apr 21, 1989
THROMBOSCREEN APTT REAGENT
K891337 · GFO
Pacific Hemostasis
Hematology · 42d
Cleared Apr 21, 1989
EDL ONE-STAGE PROTHROMBIN TIME REAGENT
K891370 · GJS
Elite Diagnostic , Ltd.
Hematology · 43d
Cleared Apr 18, 1989
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · KHE
Labeltape Meditect, Inc.
Hematology · 194d
Cleared Apr 18, 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · GKZ
Abbott Diagnostics
Hematology · 77d
Cleared Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907 · JCN
R&D Systems, Inc.
Hematology · 15d
Cleared Apr 10, 1989
DADE THROMBOPLASTIN IS
K891169 · GJS
Baxter Healthcare Corp
Hematology · 35d
Cleared Apr 10, 1989
EDL ABNORMAL COAGULATION CONTROL
K891175 · GGL
Elite Diagnostic , Ltd.
Hematology · 35d
Cleared Apr 10, 1989
EDL NORMAL COAGULATION CONTROL
K891179 · GIZ
Elite Diagnostic , Ltd.
Hematology · 35d