The following data is part of a premarket notification filed by Biotech Research Laboratories, Inc. with the FDA for Identification System For Hepatitis B Antigen.
| Device ID | BK840028 |
| 510k Number | BK840028 |
| Device Name: | Identification System For Hepatitis B Antigen |
| Classification | System, Identification, Hepatitis B Antigen |
| Applicant | Biotech Research Laboratories, Inc. 1600 East Gude Drive Rockville, MD 20850 |
| Product Code | KSJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-03 |
| Decision Date | 1985-01-25 |