The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Reagents For Gentamicin & Calibrat.
| Device ID | K843827 |
| 510k Number | K843827 |
| Device Name: | COBAS REAGENTS FOR GENTAMICIN & CALIBRAT |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCQ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-28 |
| Decision Date | 1985-02-01 |