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
1585–1608 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 12, 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012 · GGP
Instrumentation Laboratory CO
Hematology · 223d
Cleared Aug 12, 1992
DENLEY WELLPREP 2 SAMPLE PROCESSOR
K922327 · JQW
Denley Instruments, Inc.
Hematology · 93d
Cleared Aug 05, 1992
FIBRINOSTIKA TDP MICROELISA SYSTEM
K915698 · DAP
Organon Teknika Corp.
Hematology · 226d
Cleared Jul 28, 1992
POINTE 750 GLYCOMETER
K920449 · LCP
Pointe Scientific, Inc.,
Hematology · 177d
Cleared Jul 28, 1992
ACS APCT REAGENT
K921118 · GFO
Analytical Control Systems, Inc.
Hematology · 141d
Cleared Jul 28, 1992
MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM
K922084 · GKZ
Gen Trak, Inc.
Hematology · 85d
Cleared Jul 28, 1992
MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM
K922085 · GKZ
Gen Trak, Inc.
Hematology · 85d
Cleared Jul 27, 1992
DADE RECOMBOPLASTIN S
K921326 · GJS
Baxter Diagnostics, Inc.
Hematology · 131d
Cleared Jul 27, 1992
COULTER MAXM W/ AUTOLOADER
K922704 · GKZ
Coulter Electronics, Inc.
Hematology · 52d
Cleared Jul 21, 1992
GLYCOMAT HAEMOGLOBIN ANALYSER
K920198 · LCP
Drew Scientific , Ltd.
Hematology · 188d
Cleared Jul 21, 1992
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
K922031 · JOX
Medtronic Hemotec, Inc.
Hematology · 81d
Cleared Jul 21, 1992
AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K923021 · KHO
Tosoh Corp.
Hematology · 28d
Cleared Jul 13, 1992
FDP PLASMA TEST KIT
K920943 · DAP
American Bioproducts Co.
Hematology · 137d
Cleared Jul 10, 1992
COLUMNMATE II
K921676 · LCP
Helena Laboratories
Hematology · 93d
Cleared Jul 06, 1992
COULTER MH017
K921567 · GKZ
Coulter Electronics, Inc.
Hematology · 95d
Cleared Jun 29, 1992
IVOS ANALYZER
K920719 · GKL
Hamilton Thorne Research
Hematology · 132d
Cleared Jun 29, 1992
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K921465 · GKP
Helena Laboratories
Hematology · 94d
Cleared Jun 26, 1992
QBC FIBRINOGEN
K920258 · KQJ
Bd Becton Dickinson Vacutainer...
Hematology · 157d
Cleared Jun 23, 1992
NEOPLASTINE CI PLUS
K922040 · GJS
American Bioproducts Co.
Hematology · 53d
Cleared Jun 19, 1992
CD2 MONOCLONAL ANTIBODIES
K914846 · GKZ
Gen Trak, Inc.
Hematology · 235d
Cleared Jun 19, 1992
CD8 MONOCLONAL ANTIBODIES
K914847 · LIZ
Gen Trak, Inc.
Hematology · 235d
Cleared Jun 19, 1992
CD4 MONOCLONAL ANTIBODIES
K914848 · GKZ
Gen Trak, Inc.
Hematology · 235d
Cleared Jun 16, 1992
MIL CM-II COAGULATION MACHINE
K913320 · GKN
Medical Innovations Corp.
Hematology · 327d
Cleared Jun 09, 1992
HERMLE Z230H
K920207 · GKG
Labnet Intl., Inc.
Hematology · 145d