The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Legionella Indirect Fluorescent Antibod.
| Device ID | K832896 |
| 510k Number | K832896 |
| Device Name: | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. KIRYAT WEIZMANN P.O. BOX 2012 Rehovot, Israel, |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-23 |
| Decision Date | 1983-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545020941 | K832896 | 000 |
| 05391516746168 | K832896 | 000 |
| 05391516746175 | K832896 | 000 |
| 05391516746366 | K832896 | 000 |
| 05391516747554 | K832896 | 000 |
| 05391516747561 | K832896 | 000 |
| 05391516747578 | K832896 | 000 |
| 05391516747592 | K832896 | 000 |
| 00813545020866 | K832896 | 000 |
| 00813545020873 | K832896 | 000 |
| 00813545020897 | K832896 | 000 |
| 00813545020927 | K832896 | 000 |
| 00813545020934 | K832896 | 000 |
| 05391516746151 | K832896 | 000 |