Beckman Coulter, Inc. · Class II · Cleared Dec 19, 2003
| K-number | K033603 |
| Device name | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 |
| Applicant | Beckman Coulter, Inc. |
| Product code | LIG |
| Device class | Class II |
| Decision date | Dec 19, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.1810 |
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