K832896 is an FDA 510(k) clearance for the LEGIONELLA INDIRECT FLUORESCENT ANTIBOD. This device is classified as a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II - Special Controls, product code LHL).
Submitted by Biodan Medical Systems, Ltd. (Rehovot, Israel, US). The FDA issued a Cleared decision on October 14, 1983, 52 days after receiving the submission on August 23, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K832896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1983 |
| Decision Date | October 14, 1983 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |