The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Monitorx Laserx Theophylline Reagent Set.
| Device ID | K870277 |
| 510k Number | K870277 |
| Device Name: | MONITORX LASERX THEOPHYLLINE REAGENT SET |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-27 |
| Decision Date | 1987-02-18 |