The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Hemoglobin A1c Assay.
| Device ID | K173909 |
| 510k Number | K173909 |
| Device Name: | Dimension Hemoglobin A1c Assay |
| Classification | Hemoglobin A1c Test System |
| Applicant | Siemens Healthcare Diagnostics Inc. P.O. Box 6101 M/S 514 Newark, DE 19714 -6101 |
| Contact | Alan Haley |
| Correspondent | Alan Haley Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE Newark, DE 19702 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414006659 | K173909 | 000 |
| 00630414006666 | K173909 | 000 |