The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls.
| Device ID | K140654 |
| 510k Number | K140654 |
| Device Name: | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls |
| Classification | Hemoglobin A1c Test System |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK ROAD, DEPT. 09V6 AP8 Abbott Park, IL 60064 |
| Contact | Judith R Wallach |
| Correspondent | Judith R Wallach ABBOTT LABORATORIES 100 ABBOTT PARK ROAD, DEPT. 09V6 AP8 Abbott Park, IL 60064 |
| Product Code | PDJ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-14 |
| Decision Date | 2015-05-22 |
| Summary: | summary |