The following data is part of a premarket notification filed by Centocor, Inc. with the FDA for Fitc Anti-rabies Monoclonal Globulin.
| Device ID | K820499 |
| 510k Number | K820499 |
| Device Name: | FITC ANTI-RABIES MONOCLONAL GLOBULIN |
| Classification | Antiserum, Fluorescent, Rabies Virus |
| Applicant | CENTOCOR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GOI |
| CFR Regulation Number | 866.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-23 |
| Decision Date | 1982-04-16 |