The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Systems Carbon Dioxide Liquid (c02_l) Assay, Model Ref 07987100, 07506781.
| Device ID | K100289 |
| 510k Number | K100289 |
| Device Name: | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street Walpole, MA 02032 |
| Contact | Sandra D White |
| Correspondent | Sandra D White SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street Walpole, MA 02032 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-02 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595900 | K100289 | 000 |
| 00630414553177 | K100289 | 000 |
| 00630414505497 | K100289 | 000 |
| 00630414498928 | K100289 | 000 |
| 00630414000541 | K100289 | 000 |