The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fitc Murine Monoclonal Anti-influenza Type A.
| Device ID | K893579 |
| 510k Number | K893579 |
| Device Name: | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| 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 | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-09 |
| Decision Date | 1990-01-16 |