Bio-Rad Laboratories, Inc. · Class II · Cleared Dec 16, 1996
| K-number | K963934 |
| Device name | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 |
| Applicant | Bio-Rad Laboratories, Inc. |
| Product code | MMI |
| Device class | Class II |
| Decision date | Dec 16, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 862.1215 |
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