The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fitc Murine Monoclonal Anti-rsv Igg.
| Device ID | K884516 |
| 510k Number | K884516 |
| Device Name: | FITC MURINE MONOCLONAL ANTI-RSV IGG |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Leif E Olsen |
| Correspondent | Leif E Olsen WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-27 |
| Decision Date | 1989-01-13 |