The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax Test Kit For Eb-vca-g Antibody.
| Device ID | K882023 |
| 510k Number | K882023 |
| Device Name: | FIAX TEST KIT FOR EB-VCA-G ANTIBODY |
| Classification | Epstein-barr Virus, Other |
| 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 | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-17 |
| Decision Date | 1988-08-03 |