Roche Diagnostics/Boehringer Mannheim GmbH · Class II · Cleared Jun 15, 1998
| K-number | K981632 |
| Device name | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT |
| Applicant | Roche Diagnostics/Boehringer Mannheim GmbH |
| Product code | CIG |
| Device class | Class II |
| Decision date | Jun 15, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 862.1110 |
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