K812006 is an FDA 510(k) clearance for the LEGIONELLA DIRECT FLUORESCENT ANTIBODY. This device is classified as a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II - Special Controls, product code LHL).
Submitted by Centers For Disease Control and Prevention (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981, 54 days after receiving the submission on July 16, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K812006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1981 |
| Decision Date | September 08, 1981 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |