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
1273–1296 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 13, 1995
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
K953448 · GKZ
Roche Diagnostic Systems, Inc.
Hematology · 88d
Cleared Oct 06, 1995
COULTER Z 1
K952308 · GKL
Coulter Corp.
Hematology · 142d
Cleared Oct 06, 1995
MDA SIMPLASTIN LS
K952608 · GJS
Organon Teknika Corp.
Hematology · 121d
Cleared Oct 06, 1995
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K954137 · JPK
R&D Systems, Inc.
Hematology · 35d
Cleared Oct 05, 1995
POSITIVE LUPUS ANTICOAGULANT PLASMA
K945856 · GGC
George King Bio-Medical, Inc.
Hematology · 325d
Cleared Oct 05, 1995
QBC ACCUTUBE
K953340 · GKZ
Becton Dickinson Diagnostic...
Hematology · 80d
Cleared Oct 05, 1995
AVL OMNI ANALYZER
K954018 · GKR
Avl Scientific Corp.
Hematology · 41d
Cleared Sep 29, 1995
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · KHG
Abbott Laboratories
Hematology · 102d
Cleared Sep 26, 1995
THE HEPANORM HBPM/LMWH KIT
K943514 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
HBPM/LMWH CONTROL KIT
K943519 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
HEPARIN CONTROL KIT
K943520 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 25, 1995
SPECTROLYSE ANTIPLASMIN KIT
K941752 · GGP
Biopool AB
Hematology · 535d
Cleared Sep 25, 1995
QBC ACCUTUBE
K945205 · GKZ
Becton Dickinson Diagnostic...
Hematology · 335d
Cleared Sep 25, 1995
HEMA-TROL Q-CHECK
K952385 · JJY
Medical Specialties Intl., Inc.
Hematology · 126d
Cleared Sep 21, 1995
STA-COAG CONTROL [P] PLUS KIT
K952338 · GGC
American Bioproducts Co.
Hematology · 125d
Cleared Sep 20, 1995
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K952720 · JPK
Aalto Scientific, Ltd.
Hematology · 97d
Cleared Sep 12, 1995
DATACELL 18MS
K945678 · GKZ
Danam Electronics
Hematology · 298d
Cleared Sep 08, 1995
ADP REAGENT, MODIFIED
K952252 · GHR
Helena Laboratories
Hematology · 116d
Cleared Sep 08, 1995
OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL
K953498 · GKZ
Immunotech, Inc.
Hematology · 44d
Cleared Sep 05, 1995
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
K952560 · JPA
Sienco, Inc.
Hematology · 95d
Cleared Sep 01, 1995
CASCASE 480 SNSLYZER
K951497 · JPA
Helena Laboratories
Hematology · 182d
Cleared Sep 01, 1995
SF-CHECK
K952245 · JPK
Streck Laboratories, Inc.
Hematology · 112d
Cleared Aug 31, 1995
ROTACHROM HEPARIN TEST KIT
K943515 · KFF
American Bioproducts Co.
Hematology · 406d
Cleared Aug 31, 1995
ROTACHROM HBPM/LMWH TEST KIT
K943516 · KFF
American Bioproducts Co.
Hematology · 406d