The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Hemoglobin A1c, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls.
| Device ID | K130255 |
| 510k Number | K130255 |
| Device Name: | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS |
| Classification | Hemoglobin A1c Test System |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3502 |
| Contact | Judith R Wallach |
| Correspondent | Judith R Wallach ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3502 |
| 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 | 2013-02-01 |
| Decision Date | 2014-02-28 |
| Summary: | summary |