The following data is part of a premarket notification filed by Siemens Heatlhcare Diagnostics Inc with the FDA for Dimension Visa Hba1c, Model K3105a.
| Device ID | K102045 |
| 510k Number | K102045 |
| Device Name: | DIMENSION VISA HBA1C, MODEL K3105A |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Anna-marie K Ennis |
| Correspondent | Anna-marie K Ennis SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-21 |
| Decision Date | 2011-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768029974 | K102045 | 000 |