The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Dca Vantage, Model 5075.
| Device ID | K071466 |
| 510k Number | K071466 |
| Device Name: | DCA VANTAGE, MODEL 5075 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 2 EDGEWATER DR. Norwood, MA 02062 |
| Contact | Noor Malki |
| Correspondent | Noor Malki SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 2 EDGEWATER DR. Norwood, MA 02062 |
| Product Code | LCP |
| Subsequent Product Code | CGX |
| Subsequent Product Code | JIR |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414551364 | K071466 | 000 |