The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Advia Chemistry Hemoglobin A1c, Advia Chemistry A1c Calibrators.
| Device ID | K081895 |
| 510k Number | K081895 |
| Device Name: | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2009-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597300 | K081895 | 000 |
| 00630414574516 | K081895 | 000 |
| 00630414555140 | K081895 | 000 |