The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Genetic Sys Legionella Immunoflurores.
| Device ID | K842683 |
| 510k Number | K842683 |
| Device Name: | GENETIC SYS LEGIONELLA IMMUNOFLURORES |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | GENETIC SYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-08-02 |