The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fitc Murine Monoclonal Anti-herpes Type 1 Igg.
| Device ID | K881180 |
| 510k Number | K881180 |
| Device Name: | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Marie P Reeves |
| Correspondent | Marie P Reeves WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-05-13 |