K831760 is an FDA 510(k) clearance for the LEGIONELLA IFA KIT I. This device is classified as a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II - Special Controls, product code LHL).
Submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983, 68 days after receiving the submission on June 1, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K831760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1983 |
| Decision Date | August 08, 1983 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |