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
1585–1608 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
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
Cleared Jun 09, 1992
GLYCO-TEK AFFINITY COLUMN KIT
K921305 · LCP
Helena Laboratories
Hematology · 89d
Cleared Jun 09, 1992
THROMBO-CALIBRATOR KIT
K921344 · GGN
American Bioproducts Co.
Hematology · 82d
Cleared Jun 09, 1992
CASCADE 480
K921363 · GKP
Helena Laboratories
Hematology · 81d