The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista Csae Calibrator, Model Kc440.
| Device ID | K082030 |
| 510k Number | K082030 |
| Device Name: | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 |
| Classification | Calibrators, Drug Specific |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-17 |
| Decision Date | 2008-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016448 | K082030 | 000 |