The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagents For Pheno & Cobas Fp Pheno Cali..
| Device ID | K872397 |
| 510k Number | K872397 |
| Device Name: | COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. |
| Classification | Fluorescence Polarization Immunoassay, Phenobarbital |
| 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 | LGQ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-22 |
| Decision Date | 1987-07-21 |