K841162 is an FDA 510(k) clearance for the IMMPULSE GENTAMICIN ASSAY REAGENTS. This device is classified as a Fluorescent Immunoassay Gentamicin (Class II - Special Controls, product code LCQ).
Submitted by Paragon Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984, 44 days after receiving the submission on March 19, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K841162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1984 |
| Decision Date | May 02, 1984 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCQ — Fluorescent Immunoassay Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |