Abbott Laboratories · Class II · Cleared May 22, 2015
| K-number | K140654 |
| Device name | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls |
| Applicant | Abbott Laboratories |
| Product code | PDJ |
| Device class | Class II |
| Decision date | May 22, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 862.1373 |
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