The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Rapidpoint 500 System Measurement Cartridge With Calibrators.
| Device ID | K122398 |
| 510k Number | K122398 |
| Device Name: | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | Siemens Healthcare Diagnostics Inc. 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Contact | Amy Goldberg |
| Correspondent | Noor Malki Siemens Healthcare Diagnostics Inc. 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-07 |
| Decision Date | 2012-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414947556 | K122398 | 000 |
| 00630414589770 | K122398 | 000 |
| 00630414589763 | K122398 | 000 |
| 00630414589756 | K122398 | 000 |