510(k) K800847
- Device
- ENTELLAN
- Applicant
- MCB MANUFACTURING CHEMISTS, INC.
- 510(k) number
- K800847
- Product code
- KEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-08
- Date received
- 1980-04-15
- Regulation
- 864.4010
- Classification name
- Media, Mounting, Oil Soluble
- Medical specialty
- Pathology
- Review panel
- Hematology
- 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#
- 1419341
- 9610140
- 1419699
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEP #
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