The following data is part of a premarket notification filed by Paragon Diagnostics, Inc. with the FDA for Immpulse Amikacin Assay Reagents.
| Device ID | K841161 |
| 510k Number | K841161 |
| Device Name: | IMMPULSE AMIKACIN ASSAY REAGENTS |
| Classification | Radioimmunoassay, Amikacin |
| Applicant | PARAGON DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLQ |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-05-02 |