The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Protein 1 Calibrator, Protein1 Control L,m,h.
| Device ID | K071980 |
| 510k Number | K071980 |
| Device Name: | DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Anna Marie Ennis |
| Correspondent | Anna Marie Ennis DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-18 |
| Decision Date | 2007-09-11 |
| Summary: | summary |