The following data is part of a premarket notification filed by Paragon Diagnostics, Inc. with the FDA for Immpulse Theophylline Assay Reagents.
| Device ID | K840758 |
| 510k Number | K840758 |
| Device Name: | IMMPULSE THEOPHYLLINE ASSAY REAGENTS |
| Classification | Fluorescent Immunoassay, Theophylline |
| Applicant | PARAGON DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LER |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-04 |