510(k) K994112
- Device
- MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
- Applicant
- ONCOGENE SCIENCE, INC.
- 510(k) number
- K994112
- Product code
- NCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-09-29
- Date received
- 1999-12-06
- Regulation
- 866.6010
- Classification name
- System, Test, Her-2/neu, Monitoring
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WALTER P CARNEY
- Address
- 80 Rogers St. Cambridge MA US 02142 02142
FDA Registration Numbers#
- 2032839
- 1219913
- 2432235
Source Documents#
Other 510(k) Records For Product Code NCW #
Legacy Summary#
summary
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