Boehringer Mannheim Corp. · Class II · Cleared Jul 7, 1998
| K-number | K981883 |
| Device name | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 |
| Applicant | Boehringer Mannheim Corp. |
| Product code | CIG |
| Device class | Class II |
| Decision date | Jul 7, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 862.1110 |
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