The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Progesterone Calibrator (prog Cal).
| Device ID | K130698 |
| 510k Number | K130698 |
| Device Name: | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE Newark, DE 19702 |
| Contact | Anna Marie Ennis |
| Correspondent | Anna Marie Ennis SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE Newark, DE 19702 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-14 |
| Decision Date | 2013-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414948768 | K130698 | 000 |