The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Advia Chemistry Microalbumin Calibrators, _2 Calibrators.
| Device ID | K072204 |
| 510k Number | K072204 |
| Device Name: | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-08 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597560 | K072204 | 000 |
| 00630414534077 | K072204 | 000 |