The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc. with the FDA for Hba1c Advanced.
| Device ID | K182651 |
| 510k Number | K182651 |
| Device Name: | HbA1c Advanced |
| Classification | Hemoglobin A1c Test System |
| Applicant | Beckman Coulter Ireland Inc. Lismeehan O' Callaghan's Mills, IE V94 Pp63 |
| Contact | Catriona Hourigan |
| Correspondent | Catriona Hourigan Beckman Coulter Ireland Inc. Lismeehan O' Callaghan's Mills, IE V94 Pp63 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-01-16 |
| Summary: | summary |