The following data is part of a premarket notification filed by Siemens Heatlhcare Diagnostics Inc with the FDA for Advia Centaur Calibrator 30, Models 10379811/10379810.
| Device ID | K100293 |
| 510k Number | K100293 |
| Device Name: | ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS HEATLHCARE DIAGNOSTICS INC 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Ernest Joseph |
| Correspondent | Ernest Joseph SIEMENS HEATLHCARE DIAGNOSTICS INC 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-02 |
| Decision Date | 2010-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598239 | K100293 | 000 |
| 00630414598222 | K100293 | 000 |
| 00630414591049 | K100293 | 000 |
| 00630414578491 | K100293 | 000 |
| 00630414578484 | K100293 | 000 |
| 00630414294070 | K100293 | 000 |