FDA.reportPublic FDA data

510(k) K810848

Device
CYTOBUCKET MODEL 1024
Applicant
CYTOCHEM, INC.
510(k) number
K810848
Product code
IFB  
Decision
Substantially Equivalent (SESE)
Decision date
1981-04-23
Date received
1981-03-27
Regulation
864.3300
Classification name
Cytocentrifuge
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IFB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852117CYTO-TEK CENTRIFUGEMiles Laboratories, Inc.1985-06-10
K792032LEIF CENTRIFUGAL CYTOLOGY BUCKETRobert C. Leif, Ph.D.1979-11-30

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases