The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Chemistry Enzymatic Hemoglobin A1c (a1c_e) Assay.
| Device ID | K171771 |
| 510k Number | K171771 |
| Device Name: | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay |
| Classification | Hemoglobin A1c Test System |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC Drive Newark, DE 19714 -6101 |
| Contact | Alan Haley |
| Correspondent | Alan Haley Siemens Healthcare Diagnostics Inc. 500 GBC Drive Newark, DE 19714 -6101 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-14 |
| Decision Date | 2017-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414002880 | K171771 | 000 |
| 00630414002866 | K171771 | 000 |
| 00630414002859 | K171771 | 000 |
| 00630414220505 | K171771 | 000 |