The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Legionella Direct Fluorescent Antibody.
| Device ID | K812006 |
| 510k Number | K812006 |
| Device Name: | LEGIONELLA DIRECT FLUORESCENT ANTIBODY |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 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 | 1981-07-16 |
| Decision Date | 1981-09-08 |