The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Reagents, And Advia Chemistry B2-microglobulin Calibrator.
| Device ID | K110874 |
| 510k Number | K110874 |
| Device Name: | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Contact | Neil Parker |
| Correspondent | Neil Parker SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-29 |
| Decision Date | 2012-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597638 | K110874 | 000 |
| 00630414595566 | K110874 | 000 |
| 00630414590165 | K110874 | 000 |
| 00630414558226 | K110874 | 000 |