The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Hemoglobin A1c_3 (a1c_3) Automated Pretreatment Assay.
| Device ID | K110934 |
| 510k Number | K110934 |
| Device Name: | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET Walpole, MA 02032 -1516 |
| Contact | Sandra D White |
| Correspondent | Sandra D White SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET Walpole, MA 02032 -1516 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596129 | K110934 | 000 |
| 00630414571270 | K110934 | 000 |
| 00630414569512 | K110934 | 000 |