The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagents For Theophylline & Calibrators.
| Device ID | K871484 |
| 510k Number | K871484 |
| Device Name: | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 11 FRANKLIN AVE. Belleville, NJ 07109 -3597 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii ROCHE DIAGNOSTIC SYSTEMS, INC. 11 FRANKLIN AVE. Belleville, NJ 07109 -3597 |
| Product Code | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-15 |
| Decision Date | 1987-05-28 |