The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Enzyme 1 Calibrator (enz 1 Cal - Kc310).
| Device ID | K061923 |
| 510k Number | K061923 |
| Device Name: | DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-07 |
| Decision Date | 2006-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015861 | K061923 | 000 |