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
3097–3120 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 03, 1978
MEPA-1 BLOOD ANALYZER
K781606 · JJF
Medico Electronic, Inc.
Hematology · 15d
Cleared Sep 14, 1978
HEMAC LASER HEMATOLOGY SYSTEM
K781146 · GKL
Ortho Instruments
Hematology · 66d
Cleared Sep 14, 1978
QUANTICEL-HRP
K781247 · JPK
Bhp Diagnostix, Inc.
Hematology · 55d
Cleared Sep 14, 1978
HEMOGLOBINOMETER MODEL 720 B
K781361 · GKR
Innovative Medical Systems, Inc.
Hematology · 38d
Cleared Sep 14, 1978
EM-V
K781397 · KSG
Biological Corp. of America
Hematology · 34d
Cleared Sep 14, 1978
ORTHO LOW IONIC SOLUTION
K781435 · KSG
Ortho Diagnostics, Inc.
Hematology · 29d
Cleared Aug 21, 1978
CAMCO QUIK STAIN II
K781347 · IAF
Cambridge Chemical Products, Inc.
Hematology · 14d
Cleared Aug 21, 1978
WRIGHT RAPID STAIN
K781384 · IAF
Mfg Chemists, Inc.
Hematology · 10d
Cleared Aug 14, 1978
CUTTER/COMPUR MINI CENTRIFUGE
K781059 · GKF
Cutter Laboratories, Inc.
Hematology · 49d
Cleared Aug 14, 1978
HEMOLYSE
K781121 · GGK
Electrophoresis Corp. of America
Hematology · 42d
Cleared Aug 14, 1978
PC-CALIBRATOR
K781133 · KRY
Streck Laboratories, Inc.
Hematology · 39d
Cleared Aug 10, 1978
PLASMA COAGULATION CONT., ABNORMAL
K781104 · GFO
Ortho Diagnostics, Inc.
Hematology · 38d
Cleared Jul 27, 1978
HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2
K780652 · JKS
The London Co.
Hematology · 101d
Cleared Jul 27, 1978
GLOBIN-TERGE
K780817
Simmler & Son, Inc.
Hematology · 70d
Cleared Jul 27, 1978
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
K780943 · CDQ
Sclavo, Inc.
Hematology · 50d
Cleared Jul 27, 1978
ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
K780946 · JPJ
Hycel, Inc.
Hematology · 48d
Cleared Jul 27, 1978
AUTOMATED ENZYME
K780962 · KSK
Hyland Therapeutic Div., Travenol...
Hematology · 45d
Cleared Jul 27, 1978
PLATELET CONTROL
K780980 · JPK
Bhp Diagnostix, Inc.
Hematology · 45d
Cleared Jul 27, 1978
RIA TEST KIT SYS. DAMON KIQUISOL FREE
K781012 · CEC
Damon Corp.
Hematology · 41d
Cleared Jul 27, 1978
CONTROL, HEMATOLOGY, CH-60
K781077 · JPK
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 29d
Cleared Jun 30, 1978
FECATEST
K780564 · KHE
Otto C. Watzka
Hematology · 85d
Cleared Jun 28, 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSMEX PLATELET COUNTER, PL-110
K780911 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d