The following data is part of a premarket notification filed by Roche Diagnostics/boehringer Mannheim Gmbh with the FDA for Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent.
| Device ID | K981632 |
| 510k Number | K981632 |
| Device Name: | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 9115 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-08 |
| Decision Date | 1998-06-15 |
| Summary: | summary |