The following data is part of a premarket notification filed by Biotech Research Laboratories, Inc. with the FDA for Indirect Enzyme Linked Immunosorbent Assay Igg Ant.
| Device ID | K853484 |
| 510k Number | K853484 |
| Device Name: | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT |
| Classification | Antiserum, Cf, Epstein-barr Virus |
| Applicant | BIOTECH RESEARCH LABORATORIES, INC. 1600 EAST GUDE DR. Rockville, MD 20850 |
| Contact | David J Granlund |
| Correspondent | David J Granlund BIOTECH RESEARCH LABORATORIES, INC. 1600 EAST GUDE DR. Rockville, MD 20850 |
| Product Code | GNP |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1986-02-05 |