The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Lipid Calibrator, Model Kc220.
| Device ID | K061750 |
| 510k Number | K061750 |
| Device Name: | DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-21 |
| Decision Date | 2006-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768020452 | K061750 | 000 |