The following data is part of a premarket notification filed by Biotech Research Laboratories, Inc. with the FDA for Ebv-vca Antibody Assay Kit.
| Device ID | K821849 |
| 510k Number | K821849 |
| Device Name: | EBV-VCA ANTIBODY ASSAY KIT |
| Classification | Antiserum, Fluorescent, Epstein-barr Virus |
| Applicant | BIOTECH RESEARCH LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JRY |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-23 |
| Decision Date | 1982-08-12 |