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 |