K840758 is an FDA 510(k) clearance for the IMMPULSE THEOPHYLLINE ASSAY REAGENTS. This device is classified as a Fluorescent Immunoassay, Theophylline (Class II - Special Controls, product code LER).
Submitted by Paragon Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on April 4, 1984, 41 days after receiving the submission on February 23, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K840758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1984 |
| Decision Date | April 04, 1984 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LER — Fluorescent Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |