The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Legionella Dfa Kit I.
| Device ID | K830820 |
| 510k Number | K830820 |
| Device Name: | LEGIONELLA DFA KIT I |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | BIONETIC LABORATORY PRODUCTS 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 | 1983-03-15 |
| Decision Date | 1983-06-08 |