The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimensions Hb1c Kit, Model Df105a.
| Device ID | K102510 |
| 510k Number | K102510 |
| Device Name: | DIMENSIONS HB1C KIT, MODEL DF105A |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 |
| Contact | Anna Marie Ennis |
| Correspondent | Anna Marie Ennis SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768032615 | K102510 | 000 |