The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Legionella Pneumophila.
| Device ID | K822066 |
| 510k Number | K822066 |
| Device Name: | LEGIONELLA PNEUMOPHILA |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. P.O.B. 2012 REHOVOT 76120 Israel, IL |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-14 |
| Decision Date | 1982-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545023256 | K822066 | 000 |
| 00813545023249 | K822066 | 000 |
| 00813545023232 | K822066 | 000 |