The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Theophylline.
| Device ID | K850629 |
| 510k Number | K850629 |
| Device Name: | INNOFLUOR THEOPHYLLINE |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| Applicant | INNOTRON DIAGNOSTICS 6-A FARADAY Irvine, CA 92718 |
| Contact | Marija Valentekovich |
| Correspondent | Marija Valentekovich INNOTRON DIAGNOSTICS 6-A FARADAY Irvine, CA 92718 |
| Product Code | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-12 |