The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Ebna Stat Test Kit.
| Device ID | K911473 |
| 510k Number | K911473 |
| Device Name: | EBNA STAT TEST KIT |
| Classification | Test, Antigen, Nuclear, Epstein-barr 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 | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-09-25 |