The following data is part of a premarket notification filed by Oncogene Science, Inc. with the FDA for Manual Her-2/neu Microtiter Elisa (osdi Her-2/neu Elisa).
| Device ID | K994112 |
| 510k Number | K994112 |
| Device Name: | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) |
| Classification | System, Test, Her-2/neu, Monitoring |
| Applicant | ONCOGENE SCIENCE, INC. 80 ROGERS ST. Cambridge, MA 02142 |
| Contact | Walter P Carney |
| Correspondent | Walter P Carney ONCOGENE SCIENCE, INC. 80 ROGERS ST. Cambridge, MA 02142 |
| Product Code | NCW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-09-29 |
| Summary: | summary |