The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Murine Monoclonal Anti-adenovirus Igg.
Device ID | K885310 |
510k Number | K885310 |
Device Name: | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG |
Classification | Antisera, Fluorescent, Adenovirus 1-33 |
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 | GNY |
CFR Regulation Number | 866.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-29 |
Decision Date | 1989-02-16 |