The following data is part of a premarket notification filed by Oncogene Science, Inc. with the FDA for Complexed Psa Microtiter Elisa.
| Device ID | K002313 |
| 510k Number | K002313 |
| Device Name: | COMPLEXED PSA MICROTITER ELISA |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | ONCOGENE SCIENCE, INC. 80 ROGERS ST. Cambridge, MA 02142 |
| Contact | Sheryl Brown-shimer |
| Correspondent | Sheryl Brown-shimer ONCOGENE SCIENCE, INC. 80 ROGERS ST. Cambridge, MA 02142 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-31 |
| Decision Date | 2000-08-30 |