The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Legionella Immunofluorescent Antibody Test Kit.
| Device ID | K852237 |
| 510k Number | K852237 |
| Device Name: | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Contact | Monica S Krieger |
| Correspondent | Monica S Krieger GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-22 |
| Decision Date | 1985-08-22 |