The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Creatine Kinase Calibrator (ck Cal - Kc340).
| Device ID | K061702 |
| 510k Number | K061702 |
| Device Name: | DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-16 |
| Decision Date | 2006-07-10 |
| Summary: | summary |