| K-number | K911347 |
| Device name | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL |
| Applicant | Bio-Rad |
| Product code | JCM |
| Device class | Class II |
| Decision date | Jun 10, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 864.7415 |
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