The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Enzymatic Hemoglobin Ale (alc_e) Assay.
| Device ID | K200256 |
| 510k Number | K200256 |
| Device Name: | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay |
| Classification | Hemoglobin A1c Test System |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Julie Warren |
| Correspondent | Julie Warren Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2021-07-02 |