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
1897–1920 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 23, 1989
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · JPA
Bio/Data Corp.
Hematology · 39d
Cleared Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
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